Specialist / Senior Specialist, Clinical Quality Assurance Compliance (Contract)

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of Specialist / Senior Specialist, Clinical Quality Assurance Compliance (Contract). This position’s main responsibility is to support internal Study Management Teams, conduct internal and external GCP audits and to support inspection readiness activities. 

Essential duties and responsibilities include but are not limited to the following: 

Clinical Compliance and Operations:

• Conduct document reviews and audits of protocols, informed consents, clinical study reports, Investigator Brochures, regulatory submission documents, and other essential study documents as assigned.

• Conduct data reviews and audits of patient data listings.

• Support/Lead the Quality Assurance group at clinical team and cross-functional clinical development  Study Management Team meetings.

• Support/Lead GCP audits of clinical investigator sites, vendors, databases, clinical laboratories, systems and processes.

• Provide support to regulatory inspection readiness activities and internal audits of company systems and processes.

• Support /Lead the evaluation of GCP activities, policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.

• Support/Lead Clinical Quality Assurance (CQA) investigations, CAPA’s and Incident Reports.

• Provide CQA training as assigned.

Requirements:

• 2-5 years of experience in biotech/pharmaceutical or related area; GXP and GCP experience; or equivalent combination of education, training and experience.

• Knowledge of ICH-GCP and appropriate regional clinical research regulations and guidelines.

• Strong problem solving, risk assessment and impact analysis abilities.

• Flexible and able to multi-task and prioritize competing demands/work load.

• Excellent oral and written communication skills.

• Regulatory, Quality Assurance and Clinical Development.

Education:

• Bachelor of Science degree.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Director/Senior Director, Regulatory Affairs

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of Director/Senior Director, Regulatory Affairs.

The Director/Senior Director, Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders.  This individual will manage regulatory aspects of compounds through all phases of development, post-approval, and life-cycle of the product.  Further, the incumbent will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements, standards and trends within the company and industry are met.  The individual has departmental and corporate level influence and acts as an advisor/liaison to senior management in order to plan, evaluate and recommend regulatory strategy.  Externally, the individual will interface with outside regulatory agencies and business partners in regards to development, regulatory, and registration strategies.  He/she will also provide line management, people development, and performance management as well as support/lead development and implementation of department policies.

Essential duties and responsibilities include but are not limited to the following:

• Provides high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions.

• Uses extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.

• Oversees the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met.

• Reviews sections of IND/CTA, NDA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.

• Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes.

• Maintains awareness of global regulatory environment and assess impact of changes on business and product development programs.  Facilitate policy and development of standard interpretation of global regulation.

• Proactively influences internal and external regulatory policies and guidances.

• Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business.

• Trains, develops, and manages an effective regulatory team both via direct and indirect reporting structure (CMC, RA Operations, Labeling and Promotion).

• Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources.

• Leads special regulatory projects/process initiatives of high complexity.

• Proactively manages critical issues, taking leadership for the regulatory contribution.

• Supports executive team on due diligence, regulatory intelligence, and regulatory affairs initiatives.

• Serves on senior staff committee responsible for developing and implementing department policies.

• Identifies continuous improvement opportunities and takes action to improve processes and metrics for current performance and for scaling the business.

• Recruits, develops, manages and mentors regulatory professionals and drives a culture of excellence and motivates employees to perform at their highest ability.

• Rewards and recognizes employees and teams who take initiative beyond expectations to advance business goals.

Requirements:

• A minimum of 10 years in the biotechnology or pharmaceutical industry and a minimum 5 years in a Regulatory capacity with a broad background. 

• Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas and prior experience with both small molecules and biologics. 

• Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including pricing, reimbursement, regulatory requirements and market and policy trends.

• Extensive regulatory experience across value chain including IND/CTA, NDA/BLA/MAA, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing complex regulatory strategies with a proven track record of significant regulatory accomplishments.

• Demonstrated leadership excellence, proven ability to motivate and lead people in a complex, changing environment, and the professional maturity to overcome ambiguity and lead others through both, influence and direct authority.

• Strong business acumen and ability to make sound decisions that contribute positively to the business.

• Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.

• Proven ability to drive results and work successfully and influence within a cross-functional team/partnership environment with a high level of professionalism.

• Excellent verbal and written skills; Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders.

• Skilled in conflict resolution/negotiation.  Fosters open communication. Listens and facilitates discussion.

• Strong negotiating skills and ability to think creatively and develop creative solutions.

• Proven ability to build trust and respect within the organization.

• Ability to prioritize and handle multiple projects simultaneously.

• Interacts with Medivation employees and senior management.

• Interacts with external business partners and Regulatory Agencies.

• Business travel to be ~10-20% as required.

• PC literacy required; Proficient use of technology including MSOffice skills (Outlook, Word, Excel, PowerPoint, document management systems, and Internet resources is expected.).

Education:

• Bachelor’s degree required, advanced degree preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity 

Director, Project Management 

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of Director, Project Management.

This Project Manager will work closely with the multi-disciplinary research and early development teams within the New Projects division to bring new product candidates through from target validation to IND filing (or ex-US equivalent) to fill Medivation’s pipeline.  Internally, s/he will interface directly with multiple functional areas such as: pharmacology, medicinal chemistry, manufacturing, translational medicine, clinical development, regulatory affairs, quality, biometrics clinical operations, and commercial, as required by the projects s/he is assigned to manage.  The objective of this role is to work closely with the Project Team Leader to ensure effective and efficient research and development of assigned project(s).

Essential duties and responsibilities include but are not limited to the following:

• Work with the project teams to develop project plans that delineate team objectives, activities, timelines, and resources required. 

• Focus and manage the project team to accomplish the stated objectives on time and on budget. 

• Provide the project management skills to add value to each cross-functional project by ensuring excellent communication, clear direction of objectives, milestones, and timelines with a focus on budget and resources. 

• Manage highly-functioning teams in partnership with the Project Team Leader to proactively identify, manage, and quickly resolve issues and problems.

• Collaborate closely with each functional area to ensure projects are optimally staffed and are moving effectively towards their milestones.

• Inform senior management of operational, budgetary or resource issues/obstacles in a timely fashion.

Requirements:

• 10+ years experience in project management in the life science industry (including pharmaceutical manufacturers, biotechnology manufacturers and medical device manufacturers). 

• Experienced in project management within the Pharma/Biotech industry, preferably with experience in managing preclinical stage programs.

• Must have had experience in managing projects that had a =2-year timetable for completion involving tasks from a range of disciplines.

• The candidate must have an understanding of the pharmaceutical/medical products culture and the special requirements of completing projects within a regulated environment. 

• Computer programs systems:

• • Highly Proficient with the following MS Office (Word, Excel, Powerpoint) Outlook or similar calendar system, familiarity with SharePoint and Webex (or other similar systems).

  • MS Project

• Excellent interpersonal, organization, verbal and written communication skills.

• Problem-solving skills.

• Attention to detail and ability to organize and prioritize tasks in a timely and accurate manner.

• Ability to work collaboratively  in a dynamic environment.

• Strong MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• BS/BA degree required; advanced scientific degree favored.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Drug Safety Manager

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of Drug Safety Manager.

Medivation is focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation’s goal is to transform the treatment of these diseases and offer hope to critically ill patients and their families. With the approval of Xtandi (enzalutamide) capsules in late August and the early September product launch immediately following, Medivation is in the process of building and developing a world-class workforce to take the company to the next strategic level.

The Manager of Drug Safety will independently support the Drug Safety Department.  The Manager of Drug Safety will work in a role of leadership in development, implementation and maintenance of a quality system for all Drug Safety activities, encompassing processes, procedures, compliance and metrics.

Essential duties and responsibilities Include but are not limited to the following:

• Process SAE and AE reports of marketed and investigational products in accordance with all applicable regulations, guidelines, and SOPs with little or no supervision.  This includes detailed review of source documentation, assessing cases for reportability, accurate data entry, and quality check.

• Maintain regulatory and department compliance by ensuring timely completion of reports and facilitating submissions of reportable cases to regulatory agencies, study investigators, licensing partners and CROs.

• Represent the Drug Safety Department in cross-functional team meetings.

• Conduct periodic reconciliation of SAEs between the drug safety and clinical trial databases for ongoing clinical studies.

• Participate in the preparation of aggregate safety reports, such as quarterly safety reports to Ethics Committees and annual reports to regulatory authorities.

• Draft and update departmental SOPs and other work practices as assigned and maintain consistency with regulatory guidelines and good pharmcovigilance practices.

• Participate in regular audits of department SOPs with guidance from the (Director), participate in training of drug safety staff and internal and external audiences on drug safety related topics, such as investigator meetings.

• Evaluate project case workflow and offer solutions for process improvement.

• Maintain a high level of understanding of federal and international regulations and guidances so as to guide departmental policies and procedures.

• Lead team members, e.g., Drug Safety Coordinators, Drug Safety Associates and Senior Associates, to facilitate efficient case processing.

• Provide mentorship to DSAs and Senior DSAs in day to day case processing activities.

• Draw upon the knowledge of Drug Safety regulations & practices, disease specific clinical knowledge and understanding of corporate objectives to solve complex problems in creative and effective ways as well as to anticipate routine problems and mitigate them without supervisory intervention.

Requirements:

• Minimum of 6 years of relevant experience which includes 4 years in drug safety.

• Broad knowledge of domestic and international drug safety regulations, industry practices and standards.

• Must have a strong attention to detail, teamwork and initiative.

• Must have excellent written and oral communication skills, resourcefulness and personal organization skills.

• Excellent working knowledge of MedDRA and WHODRUG coding dictionaries.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• BS degree in a life science discipline, e.g., pharmacy, nursing.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Director/Senior Director,  New Products Pipeline Marketing

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Director/Senior Director,  New Products Pipeline Marketing.

The Director/Senior Director of New Products Pipeline Marketing will be responsible for commercial development and marketing activities for Medivation’s early stage products. S/he will lead efforts to quickly develop an understanding of relevant marketplaces and ultimately drive commercial strategy for new product opportunities for the company.  This position requires deep marketing, disease strategy and early drug development experience and offers the opportunity to help drive key decision-making at the executive level of the company.

This role demands strong strategic, scientific, analytical and communication skills and we are looking for an individual with a strong track record of success in these areas. You will be a key contributor to multiple cross-functional teams in leading unmet need identification, target product profile development and the overall commercial strategies for our early stage products. This individual must have excellent prioritization skills and be able to thrive in a fast-paced environment.

Duties and responsibilities include but are not limited to the following:

• Collaborate closely with our research organization to help focus discovery efforts to align with corporate goals and mission.

• Partner with Portfolio Planning to assess market opportunities and identify potential commercial value for our products.

• Work with Sr. Director of Business Development to help define commercial opportunities outside of our internal product development efforts.

• Devise commercial strategies which address unmet medical needs and maximize product value.

• Develop and gain cross-functional alignment on commercial assumptions for our new products.

• Identify and ensure commercial leadership awareness of opportunities & challenges for these programs.

• Create the commercial point of view which drives program go/no decisions.

• Provide opportunity to discuss other relevant topics (i.e. Portfolio, Disease Strategies).

• Sit on the development teams for any pipeline products to provide strategic commercial input and direction. 

• Provide regular executive management updates of progress.

Requirements:

• 10+ years experience of marketing/strategic marketing/life-cycle management.

• Ability to make sound recommendations based on appropriate market assessments.

• Demonstrate a grasp scientific concepts and early stage drug development.

• Ability to thrive in an environment of rapid change; a proven ability to work effectively within cross-functional teams as both a leader and a participant; and have a passion for science based brands that can dramatically improve patients' lives.

• Perform all company business in accordance with regulations (e.g. EEO, FDA, OSHA, PDMA, EPA, PhRMA, etc.) and company policies and procedures, immediately reporting all noted/observed violations to management.

• Frequent exposure to high level executives within Medivation is required, so excellent communication skills and sound judgment are critical skills for success.

• A successful track record with marketing and/or new product planning.

• Experience in oncology a plus.

• Documented experience in overseeing market development/ expansion activities.

• Proven ability to successfully lead/work in a cross functional team setting (clinical, medical affairs, sales, managed markets, regulatory, legal, R&D, project management).

• Demonstrates high ethical and professional standards with business contacts in order to maintain Medivation’s excellent reputation within the biotech community.

• Excellent communication and presentation skills, strong business acumen, analytical orientation, and ability to influence others.

• Demonstrated ability to create financial and operational objectives across business departments.

Education:

• Bachelor’s degree required.  Graduate degree a plus.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

SDTM Programmer (Contract)

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of SDTM Programmer (Contract). The SDTM Programmer will work in Medivation’s SDTM Programming group across Therapeutic areas. The candidate will be responsible for creating SDTM deliverables. 

Essential duties and responsibilities include but are not limited to the following:

• General SDTM mapping skills:

• • 1) Identify required domains based on CRF/external data.

  • 2) Define and develop mapping/programming specifications per study requirements.

  • 3) Understand the usage of CDISC Metadata Submission Guidelines for CRF annotation.

• Knowledge of SDTM including SDTM mapping strategies and conventions including Controlled Terminology.

• Experience and expertise across different versions of SDTM and associated implementation guides.

• Follow SDTM dataset specifications to create SDTM datasets (as needed).

• Interact and communicate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing and Medical Monitors to address programming related study deliverables.

• Write, test and validate SAS programs to produce SDTM datasets.

• Understand and execute department-, product- and study-level macros and utilities.

• Other duties as assigned.

Requirements:

• 5+ years clinical programming experience using SAS (Manager).

• Experience in delivering on complex programming assignments and analysis.

• Hands-on experience of CDISC methodologies and SDTM mapping.

• Experience in Oncology Trials a plus.

• Strong SAS programming skills to manipulate/restructure data and implement coding algorithms and logic.

• Computer programming using SAS and expertise in using SAS Statistical and Reporting Procedures.

• Understanding of computer operating systems, word processors, document applications.

• Drug development process.

• Excellent verbal and written communication skills.

• Ability to effectively collaborate in a dynamic environment.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• Bachelors or Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject. 

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity 

System Administrator

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of System Administrator.

The System Administrator is responsible for the end-to-end requirements elicitation, design, testing, and successful transition of Medivation’s internal and vendor-enabled infrastructure, massaging, storage, network, security & continuity services. Additional responsibilities include planning, organization, and management of related programs, projects and ITIL processes to ensure service level consistency and optimization. The System Administrator will also help drive architectural roadmaps for Workplace, Network and Infrastructure services and lead activities to resolve hardware and software problems in a timely fashion.

Essential duties and responsibilities include but are not limited to the following:

Strategy & Planning

• Responsible for installing, configuring, provisioning, maintaining/supporting the systems related to the IT infrastructure, including network management.

• Partner with vendors to ensure operational requirements are met, maintained and evolve.

• Act as the technical resource for multiple projects according to industry-standard best practices, Regulated and ITIL based requirements.

Acquisition & Deployment

• Work with Engineering, Service Desk teams and vendors to facilitate deployment, monitoring, maintenance, development, upgrade, and support of IT services and associated processes and procedures.

Operational Management

• Manage Medivation solutions to meet requirements in development, test, and production environments. Installs company wide system installations.

• Technical skills and knowledge that extends across Application / Server / Storage / Network technologies to troubleshoot and provide system level guidance/solutions.

• Analyze, monitor, configure, and maintain the existing system and identify possibilities for improvement.

• Practice Change, Problem, Incident, Request, Asset & Configuration Management best practices including maintenance of component inventory and related documentation.

Requirements:

• 5-7 years of experience delivering operational excellence.

• Good understanding of systems integration (Hardware, Networking, Storage, and Virtualization) and OS operation in a cross-platform environment (Linux/Windows/other UNIX operating systems).

• Ability to interpret all technical manuals and schematics including engineering orders supporting the monitoring, triage and repair of the Network, IT and/or ABS system.

• Good understanding of interconnect components and protocols such as DS1, DS3, CDMA, EVDO , MPLS, BGP, LAN/WAN, IP routing, 802 WIFI protocols, router technologies, and wireless networks.

• Operational support experience with Windows & Cisco Services, Exchange Server, VMWare vSphere, Linux, Hadoop, VDI, Zerto, Avamar, DataDomain, EMC VNX, Isilon and Flash Storage, Okta, Solarwinds, Axway.

• Exposure to Hadoop like distributed architecture practices/genomic sequencing environments.

• Administrative scripting experience with either Perl/Python/shell scripting.

• Experience and familiarity with ITIL process and practice is preferred.

• Familiarity with databases and SQL competence.

• Experience in a biotech or pharmaceutical industry with knowledge of GxP and SOW compliance preferred.

• Able to work effectively and prioritize under deadlines in a fast-paced, changing environment.

• Exceptional organizational skills and attention to details.

• Strong analytical, trouble-shooting and problem solving skills.

• Strong interpersonal, written, and oral communication skills.

• Able to conduct research into issues and products as required.

• Highly self-motivated and directed.

• Strong customer service orientation.

• Experience working in a team-oriented, collaborative environment.

• 24/7/365 on-call availability for emergency escalations.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• Four-year university degree or college diploma in the field of computer science and/or 10 years equivalent work experience. 

• Certifications in Microsoft, Linux, Virtualization technologies.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Senior Director, Biologics Technical Operations

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Director, Biologics Technical Operations.

The Senior Director of Biologics Technical Operations will lead the development, planning, and implementation of Biologics product and process development for projects and technologies from the laboratory through pilot plant and manufacturing scale.  He/She will provide strategic direction, tactical oversight and technical expertise for all activities within the Product/Process Development and Manufacturing area in Biologics Technical Operations, and will be responsible for post launch technical support for trouble shooting and change management.

Essential duties and responsibilities include but are not limited to the following:

• Provide leadership, vision, and management to the Biologics Technical Operations organization which includes departments of Cell Culture Bioprocess, Purification Bioprocess, Biopharmaceutical Sciences, Bioassay, and Protein Analytical Chemistry.

• Effectively apply expertise in Biologics drug development and manufacturing.

• Advocate for resolution to production issues and deviations through effective departmental partnerships.

• Formulate, recommend, and manage manufacturing policies, schedules, procedures and programs for both drug substance and drug product.

• Routinely interface with other departments, such as Small Molecule Technical Operations, Supply Chain, Early Development, Regulatory, Project Management, Quality Assurance and Quality Control.

• Recommend capital expenditures and aid in the realization of capital projects.

• Evaluate and recommend best safety practices.

• Track and trend relevant technical process metrics to ensure operations are performing effectively and efficiently.

• Oversee the overall business approaches of utilizing the resources in CROs and CMOs, and be accountable for the overall activities.

• Develop and implement comprehensive development activities reports.

• Review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.

• Develop department goals, objectives, and metrics.

• Implement and evaluate continuous improvement opportunities.

• Optimize department resources to ensure maximum production value.

• Develop and share best practices across organizations and across sites as needed.

• Develop and participates in site efforts to ensure consistency in procedures, practices and policies.

• Evaluate new technologies for use in production.

• Develop training.

• Implement new recombinant protein production processes and technologies.

Requirements:

• Requires 17+ years of progressive experience in the biopharmaceutical/biotech industry, GMP production facility environment.

• Significant experience working in an outsourcing environment as well as building internal laboratories.

• A strong track record of scientific achievements.

• Excellent written and oral communication skills.

• Proven record of building and leading a team.

• Strong leadership skills.

• Thorough understanding of the product development and manufacturing processes.

• Ability to interpret and communicate information both internally and to external suppliers.

• Ability to prioritize, manage multiple tasks, and meet deadlines.

• Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices.

• Excellent interpersonal and leadership skills and abilities.

• Understands and appreciates the value of Process Excellence including key tools like Design Excellence, 6 Sigma, Lean MFG and DOE.

• Prior experiences in managing one or multiple functions of Biologics technical operations including Cell Culture Bioprocess, Purification Bioprocess, Biopharmaceutical Sciences, Bioassay, Protein Analytical Chemistry, Manufacturing.

• Led CMC team function for Biologics projects.

• Experiences in early development as well as late stage/commercial Biologics projects.

• Approximately 10-25% level of travel may be needed for the interactions with CMOs or CROs for critical project activities, and for representing Medivation to present and/or participate in professional conferences.

• Working in normal office working environment and attending internal and external meetings.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• Ph.D. degree in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Analytical Chemistry, Cell Biology, and related fields.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Manager/Senior Manager, Publication Planning

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Manager/Senior Manager, Publication Planning.

The Manager/Senior Manager of Publication Planning will be responsible for the successful development and tactical execution of a therapeutic product’s publication plan in alignment the product’s lifecycle strategy. The Manager/Senior Manager of Publication Planning will manage the publication plan over the course of its lifecycle and serve as the primary contact for all publication activities in collaboration with a cross-functional group to include Medical Affairs, Clinical Development, Pre-Clinical Development, Biometrics, and other relevant Corporate functions. Forging a productive and compliant partnership with Alliance partner(s), as applicable, will be essential. The candidate will report to the Director, Scientific Communications who, in turn, reports to the VP of Medical Affairs.  

Essential duties and responsibilities include but are not limited to the following:

• Develop specific publication plan(s) for assigned therapeutic products’ data generation programs (clinical, pre-clinical, health economics, etc.) and manage execution of publication plan(s)

• Serve as primary publications liaison with relevant Corporate functions and Alliance partner(s), as applicable

• Manage external medical writing agencies, including medical writers, to develop timelines and manage the process for writing/creating, reviewing, approving, and submitting publications

• Arrange publication assistance to investigators with medical writing contacts as well as manage the required review process.

• Ensure publications are developed in compliance with company guidelines and SOPs as well as industry guidelines (ICMJE Guidelines, GPP, etc.).

• Manage congress abstract planning and execution for submissions and poster/presentation development.

• Manage maintenance  and regular update of the publication planning and management database and update key stakeholders of publication status and progress.

• Support discussions on healthcare providers’ medical education gaps for development of educational objectives and publication tactics by providing strategic input.

• Support publication budget planning and management.

• Liaise with relevant Corporate functions and Alliance partner(s), as applicable, to ensure appropriate communication on publications-related activities including manuscripts and congress abstracts/posters/presentations.

• Lead development of publication scientific statements.

• Support high-quality execution of Corporate-wide initiatives.

• Develop, track, execute, and report on goals and objectives.

Requirements:

• Solid experience in publication management in the pharmaceutical or related industry (>3 years).

• Proven success with leading and managing medical writing agencies as well as track record for consistently meeting or exceeding quantitative targets.

• Working knowledge of applicable publications-related guidelines as well as legal, regulatory, compliance, and clinical/medical affairs.

• Experience with project management.

• Experience with partnerships and strategic alliances, both internal and external to the Company 3 to 5 years of experience in project management and/or publication management in the pharmaceutical or related industry.

• Professional knowledge and skills working with oncology therapeutics and/or in prostate cancer preferred.

• Values based collaborator – respectful, accountable and collaborative.

• Ability to relate and work with a wide range of people from a variety of disciplines to achieve results.

• Successful and superior influencing skills across all levels of the organization and external collaborators.

• Appreciation of diversity and working across multiple cultures.

• Ability to build positive and effective working relations throughout the organization and with business partners.

• Strong time management and organizational skills.

• Ability to manage multiple projects in a fast paced environment.

• Knowledge of document version control and related processes and systems.

• Skilled in multiple computer-based tools, in addition to software programs such as MS Word, PowerPoint, Excel, etc.

• Effective written and verbal communication skills.

• Problem solving and risk-mitigation skills.

• Solutions-oriented.

• Confident, positive attitude, enthusiastic and charismatic.

• Familiarity with publication planning and management software preferred.

Education:

• Bachelor’s degree in biology, pharmacy, or other related scientific field; advanced degree and/or certification preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Director/Senior Director, Clinical Development (M.D.)

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of Director/Senior Director, Clinical Development.

Medivation is evaluating novel therapeutics including those in preclinical stages of development. The candidate will be expected to lead projects focused on early phase development of oncology compounds from IND enabling studies to first in human studies through to proof of concept (phase 2).  Internally, s/he will interface directly with personnel in research/discovery, medicinal chemistry, pharmacology, toxicology, biomarkers/predictive diagnostics, clinical operations, regulatory affairs, biometrics, and others to ensure proper design, monitoring, oversight and interpretation of both preclinical and clinical experiments. Externally, s/he will be a liaison to investigators and key opinion leaders and participate in the interpretation of presentation of relevant preclinical and clinical data.

Essential duties and responsibilities include but are not limited to the following:

• Leading multi-functional teams in the identification and development of oncology compounds.

• Collaborating with preclinical and translational medicine colleagues in assessing the potential of new compounds for development.

• Providing clinical expertise on appropriate design of supporting preclinical research experiments.

• Identifying, evaluating and developing appropriate biomarkers for clinical implementation.

• Providing clinical input towards the design and interpretation of IND-enabling toxicity studies.

• Evaluating and implementing clinical development plans of early stage compounds.

• Working with the IND filing team to develop and file INDs; including completion of relevant clinical sections, Investigator Brochures, and protocols.

• Designing, implementing, medical monitoring, and interpreting results for phase 1 and 2 clinical trials.

• Addressing and resolving medical/safety/eligibility questions from participating clinical trial sites.

• Writing and reviewing study reports, and international regulatory documents participating in the selection of preclinical and clinical contract research organizations (CROs) and other vendors.

• Participating in the planning and management of advisory boards, investigator meetings, and other scientific committees.

Requirements:

• Minimum of 5 years industry experience, immunology or oncology experience preferred. 

• Candidate must have excellent verbal and written skills. 

• Candidate must also be able to work collaboratively in a dynamic cross-functional environment.

• Prior training and experience with Good Clinical Practice (GCP), prior experience with successful IND submissions.

• The breadth and depth of the candidate’s experience will determine title of the position.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint); Adobe Acrobat.

Education:

• M.D./D.O. degree required, subspecialty and board certification in oncology preferred but not required.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Senior SDTM Programmer

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior SDTM Programmer.

The Senior SDTM Programmer will work in Medivation’s SDTM Programming group across Therapeutic areas.  The candidate will be responsible for programming SDTM development and validation and participating on developing infrastructure.   

Essential duties and responsibilities include but are not limited to the following:

• General SDTM mapping skills:

• • Identify required domains based on CRF data.

  • Understand the usage of CDISC SDTM Guideline rules for annotation.

  • Define and develop mapping solutions per study requirements and Validate SDTM programming.

• In-depth technical knowledge of SDTM including SDTM mapping strategies and conventions, Oncology and other specific therapeutic area conventions, Controlled Terminology language and expertise across different SDTM implementation guides.

• Knowledge of CDASH and end-to-end data standardization.

• Write CDSIC standard dataset specifications and follow specifications to create SDTM and ADAM datasets (as needed).

• Programmer for multiple studies for SDTM study deliverables related to statistical and clinical programming as needed.

• Represent the SDTM team at Study Management Team and Clinical Development meetings to address deliverables and timelines as needed.

• Request for resourcing to adequately staff projects as needed.

• Assist in the review of key study-related documents produced by other functions, e.g. SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans and other clinical documents as related to SDTM.

• Provide input to and participate in intra-departmental meetings.

• Provide support to and mentor junior programmers and contractors Write, test and validate SAS programs to produce analysis datasets, TLGs and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications as needed.

• Contribute to the continuous improvement of SDTM process.

Requirements:

• 7+ years clinical research and development programming experience using SAS.

• Experience in Oncology Trials.

• Drug Development (pre-, early, late and/or observational) in related industries or academic research.

• Computer programming using SAS and expertise in using SAS Statistical and Reporting Procedures.

• Understanding of computer operating systems, word processors, document applications.

• Fundamentals of project planning and management.

• Drug development process.

• Senior level SAS programmer with experience in delivering on complex programming assignments and analysis.

• Core knowledge and extensive hands-on experience of CDISC methodologies and SDTM mapping.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint). 

Education:

• Bachelors or Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Director, Clinical Trial Operations

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Director, Clinical Trial Operations.

A Director of Clinical Trial Operations works closely with Clinical Operations and Clinical Development leadership to ensure that all clinical trials and programs are managed per corporate objectives and standard operating procedures/work instructions. This role will also be an active member of the Clinical Operations Senior Management group.

Essential duties and responsibilities include but are not limited to the following:

• Manage and partner with study leads to ensure that study protocols are executed to meet corporate objectives and in compliance with Medivation Standard Operating Procedures and Work Instructions.

• Work with Associate Directors and Sr. Clinical Project Managers to manage program level operational strategy, resourcing, and budgets.

• Evaluate, select and manage external service providers across multiple studies.

• Develop and present Clinical Operations organizational goals and/or activities.

• Partner with other group leaders within Clinical Operations and Clinical Development to identify and to improve best practices.

Significant Contacts:

• Interacts with Medivation employees.

• Site personnel (e.g., Principal Investigators, Study Coordinators).

• External service providers.

Requirements:

• ~12 years applicable industry experience in drug development; Multinational Phase III Urology or Oncology (solid tumors and/or lymphoma) experience preferred but not required.

• Licenses or Certifications: Clinical Research certification preferred, but not required.

• Proficiency with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems.

• Proven ability to recruit, retain, organize, and motivate clinical operations personnel.

• Must be self-motivating as well as able to follow directions precisely; prioritize and manage a large volume of work; show attention to detail.

• Strong interpersonal skills and professional attitude are essential as this individual will partner with various team members and functional groups for clinical studies and business performance.

• Thorough knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials.

• Ability to be flexible and adaptable to changing business needs.

• Relevant experience in clinical study execution.

• Excellent communication and interpersonal skills.

• Must be able to write clearly and summarize information effectively.

• Must be able to present complex information to various audiences.

Education:

• BS/BA in Life Science or related discipline; Advance degree (MS, MPH, MHS, Ph.D., MBA) preferred, but not required. 

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Director / Associate Director, Purification Bioprocess

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Director / Associate Director, Purification Bioprocess.

The position will provide key technical support for the purification bioprocesses of manufacturing and will contribute to the purification process development for the Biologics pipeline projects and products at Medivation. He/She will be responsible for process development in Purification, technology transfer and manufacturing process troubleshooting to ensure the quality of the Biologics products.  

Essential duties and responsibilities include but are not limited to the following:

• Lead the Purification Bioprocess development team for downstream process development and manufacturing.

• Technical proficiency in protein purification process development and manufacturing of Biologics products is required.

• Solid knowledge and experiences in protein chemistry and process engineering design is essential. Proficient in the purification bioprocess for recombinant proteins and recombinant monoclonal antibodies is desirable.

• Responsible for technology transfer, product scale-up, and process optimization. Interfaces with internal departments and external contract manufacturing organizations (CMOs)/ contract research organizations (CROs) to ensure processes operations are compatible.

• Author and revise batch records and SOPs as needed to accurately reflect purification process steps.

• Accountable for ensuring results are delivered on time and aligned with Biologics Technical Operation’s mission and goals. Be detail orientated with excellent documentation skills.

• Support all operations associated with protein purification bioprocess in CMOs including but not limited to chromatography, filtration, centrifuge, etc.; and monitoring and sampling of lab, pilot, and manufacture scales.

• Adhere to Good Manufacturing Practices and standard operating procedures. Involved in results generation of process characterization and process validation to meet the project needs.

• Address production issues in collaboration with quality and regulatory teams. Conduct investigations for manufacturing issues.

• When needed, performs experiments to troubleshoot issues associated with purification processes.

• Effective communicator of ideas, project goals and results internally and externally with CROs/CMOs.

Supplementary Responsibilities:

• Acts as a mentor for those with less experience, provides training and emphasizes best practices.

• Supports the recruitment of top talent for the build-up of Pharmaceutical Operations at Medivation.

In close cooperation with supervisor performs the following activities:

• Expand purification development and manufacturing capabilities internally and across CROs and CMOs.

Requirements:

• Minimum 10 years’ experience working in a cGMP-regulated environment for proteins manufacturing within biotechnology/biopharmaceutics industry.

• Minimum 7 years of management experiences in biotech/biopharmaceutical industry.

• Experiences with technology transfer of manufacturing process technology.

• Experience working in an outsourcing environment as well as building internal laboratories is a plus.

• Knowledge of cGMP’s, regulatory agency guidelines, validation practices, and other relevant regulatory requirements.

• Demonstrate supervision and interpersonal skills to develop effective working relationships across functions in the dept.

• Excellent written and oral communication skills.

• Must be scientifically knowledgeable, team-orientated, and passionate in biopharmaceutical development.

• Proficiency in bioprocess related software and computer operations.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• Ph.D. or M.S. in biochemistry, chemical/biochemical engineering or related disciplines with minimum of 15 years relevant industry experiences post Ph.D., or 18 years relevant industry experiences post M.S.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Scientist II/Senior Scientist, Bioassays

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of Scientist II/Senior Scientist, Bioassays.

The Scientist II/Sr. Scientist in the Bioassay group will be responsible for the development, optimization and qualification of robust in vitro bioassays in house suitable for the characterization of biological potency of therapeutic biologics or small molecule drug candidates.  She/he will serve as tech lead and SME to transfer the optimized bioassays to CROs for further phase-appropriate assay validation used for lot release and/or stability study under GMP.  She/he will be accountable for experimental design, data analysis, data interpretation, trouble shooting and providing scientific input to the the internal and external resources and/or partners. 

Essential duties and responsibilities include but are not limited to the following:

• Responsible for the development and optimization of bioassays including cell-based, MOA-reflective bioassays (e.g. reporter, proliferation, cytotoxicity and ADCC) and immuno-binding assays (such as ELISA, competitive ELISA, MSD-based, AlphaLISA).  Hands-on experience on Biacore and FACS-based assays is plus.

• Responsible for the identification, technical assessment and audit of CRO candidates associated with potency assay validation and sample testing for lot release.

• Responsible for drafting or co-drafting GXP-compliant SOPs, validation protocol and technical reports by working together with the internal quality group and outside partners (CROs).

• Accountable for timely transfer of in-house optimized bioassays to CROs or to in-house Quality Control laboratories and serves as SME to provide scientific input for the acceptance criteria of validation protocol, justification of lot release specifications, SOP, validation execution and trouble-shooting.

• Responsible for managing contract research organizations (CROs) to deliver thorough and reliable packages related to potency assay results. 

• Recommends and develops additional bioassays for further product characterization fulfill the agency’s requirements or requests.

• Assesses and implements value-added new technologies and trends to build robust, accurate and proprietary potency assays in support of Medivation’s biologics pipeline.

• Performs duties in accordance with bio-safety and general safety regulations.

• Contributes to regulatory submissions including INDs and BLAs by working with CMC regulatory affair colleagues.

• Effective communicates ideas, rationale of experiments, and results to project team members.

• Provides SME opinions and input in internal and external cross-functional project teams. Contribute to external publications and conference presentations.

Requirements:

• For Scientist II, 4+ years of industry experience in bioassay development and qualification/validation under Research and GXP modes.

• For Sr, Scentist, 7+ years of industry experience in bioassay development and qualification validation under Research and GXP modes.

• A strong track record of developing different types of cell-based and immuno-binding assays and implementing data analysis tools with strong statistic foundation from concept to the end.

• Enriched experience in the identification of competent CROs and effective management of CRO collaborations throughout tech transfer, assay validation and sample testing.

• Recognized bioassay SME who proactively contribute value-added opinions in the cross-functional CMC team meetings.

• A strong track record of scientific achievements.

• Excellent written and oral communication skills.

• Proven ability to learn new ideas and technologies with creative and “can do” attitude.

• Significant experience working in an outsourcing environment as well as in internal laboratories.

• Experiences in early development as well as late stage/commercial Biologics projects.

• Thorough understanding of biological Quality Control output.

• Ability to make decisions affecting direction of the project and assumes responsibility for meeting project timelines.

• Ability to prioritize, manage multiple tasks, and meet deadlines.

• Ability to interpret and apply cGMP, USP, regulatory requirement and industry best practices.

• Excellent interpersonal and leadership skills and abilities.

• Approximately 5-10% level of travel may be needed for the interactions with CMOs or CROs for critical project activities, and for representing Medivation to present and/or participate in professional conferences.

• Working in normal office and laboratory environment and attending internal and external meetings.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint); Adobe Acrobat.

Education:

• Ph.D. in Biochemistry, immunology, chemistry or cellular biology.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Director, Patient Advocacy Relations

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of Director, Patient Advocacy Relations.

The Director, Patient Advocacy Relations is responsible for fulfilling Medivation's commitment to build and maintain strong relationships with patients groups, key national and regional community groups, and to enhance our company's patient focused efforts. This individual will develop and implement strategy and tactics that support the mission of Patient Advocacy groups, and the goals of Medivation. The position reports directly to the Senior Director, Market Access and also works in partnership with various stakeholders including the brand teams, legal, regulatory, commercial team members, and Medivation’s collaboration partner to support efforts to get our medicines to the people who need them.

Essential duties and responsibilities include but are not limited to the following:

• Develop long-term and annual strategic plans to support patient advocacy outreach that aligned with Medivation’s goals and priorities.

• Establish, build and strengthen relationships with Patient Advocacy groups within key therapeutic areas (Currently prostate cancer) where Medivation has current treatment option.

• Develop a broad network of contacts with targeted association executives and staff and lead relationship building and activities of mutual interest with these stakeholders.

• Serve as an external ambassador for the company’s patient-centric programs: Communicate news, solicit feedback, manage sponsorship budget, and attend events on behalf of Medivation to demonstrate our commitment to the targeted patient advocacy committee.

• Prepare Medivation senior leadership and spokesperson for advocacy interactions through creation of background documents and message alignment.

• Collaborate with cross-functional team members and Medivation’s alliance partners such as the market access team members, brand teams, commercial leaders, legal and regulatory to support efforts to get our medicines to the people who need them.

• Ability to Travel =50% of time.

Requirements:

• Minimum of 5-7 years in the Pharmaceutical industry and is familiar with the drug development process.

• Minimum 7 years experience in patient advocacy, advocacy relations experience or similar function/experience with a demonstrated track record of succuss; Experience in prostate or oncology preferred. Experience with partnerships and strategic alliances is also preferred. 

• Ability to meet job demand while maintaining a significant travel schedule.

• Demonstrated ability to work in a fast pace environment and manage multiple responsibilities and priorities.

• Excellent relationships with existing advocacy organizations and relevant KOLs. Be able to proactively drive communication between Medivation and leading advocacy organizations.

• Demonstrated ability to cultivate and manage challenging relationships as well as proven skill in crisis management, issues preparedness, and negotiation.

• Understand the pharmaceutical/ biotech business model, regulatory process and communications guidelines.

• Ability to influence in a proactive, objective and diplomatic manner.

• Solid speaking, writing, and budgeting skills. Ability to present to groups of all sizes, sometimes at short notice.

• MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• Bachelor's Degree required.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity, M/F/D/V

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Medivation, Inc. will consider qualified applicants in compliance with the “San Francisco Fair Chance Ordinance.”

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Senior Scientist / Associate Director, Clinical Pharmacology & DMPK 

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Scientist / Associate Director, Clinical Pharmacology & DMPK.

The position’s primary purpose is to evaluate the clinical pharmacology, drug metabolism, and pharmacokinetics (DMPK) properties of drug candidates from Drug Discovery through NDA.  The employee will be responsible for providing clinical pharmacology and DMPK expertise to project teams; writing assigned sections of protocols and reports; overseeing bioanalytical method validation; and reviewing and preparing documentation for regulatory submissions.  The employee will collaborate with colleagues within Discovery Research, Early Development, Clinical Development, Pharmaceutical Operations, Biometrics, and other departments in a team-oriented environment.  

Essential duties and responsibilities include but are not limited to the following:

• Responsible for the scientific/technical aspects of assigned preclinical studies from conception through final report, including protocol development, budget (as appropriate), timelines, sample handling/processing, bioanalysis (through CRO), and PK data analysis/interpretation.

• Responsible for toxicokinetic (TK) sample collection/handling procedures, bioanalysis, and data analyses for toxicology studies.

• Responsible for assessing and recommending doses/regimens for molecules in clinical development in collaborate with clinicians, biostatisticians, and other project team members.

• Responsible for reviewing and preparing documentation intended for regulatory submissions, including the relevant sections of INDs and NDAs (CTD items 2.4, 2.6.4, 2.6.5, 2.7.1, 2.7.2, and QBR).

• Other duties as assigned.

Requirements:

• Required: PhD, postdoctoral experience, and a minimum of 5-8 years of direct experience in Biotech/Pharmaceutical industry or MS with 10+ years of direct experience. Title commensurate with experience.

• Experience with TK, PK, and PK/PD analyses using standard software (e.g., Phoenix) is required.

• Experience with SymCYP, GastroPlus, and population PK/PD methods preferred.

• Excellent verbal and written communication skills.

• Ability to effectively collaborate in a dynamic environment.

• Interacts with Medivation employees, external consultants, and CROs.

• MSOffice skills (Outlook, Word, Excel, PowerPoint, Project).

• Phoenix required; SymCYP, GastroPlus, and population PK/PD methods preferred.

Education:

• MS/PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related discipline.

• May require certification or advanced training in assigned area.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Quality Document Control Manager

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Quality Document Control Manager.

The Quality Document Control Manager is responsible for ensuring proper and timely execution of controlled document processes. This role conducts assessments of complex electronic workflows and business processes to recommend solutions and improvements, is familiar with standard GxP concepts, practices, and procedures, relies on extensive experience and judgment to plan and accomplish goals, and may lead and direct the work of others.  A wide degree of creativity and latitude is expected.  The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment and will be communicating with staff at all levels of the company.  Strong initiative and follow through is essential for this job.

Essential duties and responsibilities include but are not limited to the following:

• Serve as controlled document subject matter expert (SME) and independently oversee controlled document processes for new, revised, and archived documents ensuring compliance to company controlled document procedures and related regulations.

• Author and update controlled document procedures as needed.

• Manage and maintain controlled documents in MasterControl with little or no assistance/direction.

• Independently review SOP/Work Instruction content and exercise judgments to provide suggestions to author to ensure alignment with Medivation controlled document procedures and best practices.

• Assist in the development, administration and validation of electronic Quality Management Systems.

• Lead execution of UAT of MasterControl and Please review during validation.

• Track controlled documents to ensure reviews and approval are completed within MasterControl.

• Coordinate the review, finalization, and archival of Medivation policies, procedures and other controlled documents.

• Edit and proofread controlled documents for consistency of document format and adherence to Quality systems processes and procedures.

• Follow GxPs and Medivation SOPs and Policies.

• Implement and utilize advanced Word processing and automation features of MS Office software.

• Lead the implementation of document control process improvements.

• Provide back-up support as needed for other functions within Quality Document Control Department.

• Provide support for the Quality Systems during internal audits.

• Participate as a member of the Quality Document Control team and offer support, as needed.

• Contribute to departmental and company goals by suggesting and implementing process improvements.

• Other tasks as assigned, for example:

• • Assist with archival of GLP study reports, GMP documents such as product specifications and batch records, clinical trial master files, and Quality Management files including training records, consultant files and vendor qualification / audit files.

  • Participate in Document Control QC Reviews.

  • Perform validation/verification activities.

  • Work with QA Validation and IT to execute validation/verification test for Quality Management Systems.

Requirements:

• 8 years of experience in working with documentation in a regulated industry.

• Knowledge of GxP concepts and guidelines.

• Experience with document control activities required.

• Experience with MasterControl or other advanced Document Control system required.

• Requires strong written, oral, interpersonal, and communication skills.

• Effective knowledge of maintaining a document and data control system.

• Effective organization and planning skills.

• Demonstrated ability to deal with frequent changes, delays or unexpected events.

• Must be able to follow established policies and procedures, and comply with regulatory requirements related to documentation.

• Demonstrated ability to perform detail oriented work with a high degree of accuracy and completeness.

• Must have general understanding of CLIA and FDA regulatory requirements as they relate to documentation.

• Exceptional communication skills, both verbally and written materials (fluency in English).

• Ability to recognize problems, recommend and implement solutions.

• A logical and organized thought pattern is required.

• Extensive MS Word processing and formatting experience required.

• Strong written communication skills.

• Experience using an electronic document management system.

• Technically Savvy.

• Experience in automating process utilizing MS Office products.

• Experience using an electronic document management system.

• Excellent attention to detail.

• Ability to effectively communicate and share knowledge with a team.

• Proven ability to work under tight deadlines and pressure in a composed manner.

• Learning Management System experience a plus.

• Strong team player.

• Comfortable communicating with all levels of staff, including chief executives.

• Interacts regularly with personnel in Quality. 

• PC literacy required; Advanced MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• B.S./B.A. biological sciences, physical sciences or equivalent experience.

• MCP preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Associate Director of Portfolio Planning, XTANDI-Prostate Cancer 

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Associate Director of Portfolio Planning, XTANDI-Prostate Cancer.

The Associate Director of Portfolio Planning, XTANDI-Prostate Cancer will lead market research and support forecasting efforts for XTANDI. This position reports to the Director of Portfolio Planning-Xtandi Prostate Cancer. You will be a key contributor to the XTANDI commercial team, leading primary and secondary research activities which directly inform the development of XTANDI brand strategy.  You will support the development and management of forecasts for current in-line indications and potential future indications for XTANDI. In addition, you will play a critical role in communicating the performance of XTANDI and advocating for data driven commercial strategies to stakeholders across Medivation including executive leadership.

This role demands strong demonstrated analytical, strategic skills and the ability to communicate effectively with cross functional teams including executive leadership. This individual must be able to thrive in a fast-paced environment.

This product is partnered with Astellas Pharma, Inc, a Japanese company with US headquarters near Chicago, IL. This position will have contact with our partner company and maintaining our excellent relationship is a must.

Essential duties and responsibilities include but are not limited to the following:

• Support commercial decision-making and XTANDI brand strategy development by delivering actionable insights about key stakeholders and the marketplace.

• Design and implement primary and secondary market research studies, select and hire research vendors, develop and present findings/insights/recommendations to XTANDI brand team and stakeholders across Medivation including executive leadership.

• Support the development/presentation of XTANDI quarterly/annual and long range revenue forecast, using primary and secondary market research.

• XTANDI and marketplace performance monitoring.

• Ad Hoc analysis of current marketplace trends.

• Monitor unmet needs of key internal stakeholder groups and recommend strategies to increase stakeholder satisfaction.

• Collaborate with co-promote partners and gain consensus regarding market research plans and joint forecasts.

• Manage projects within set budget guidelines.

Requirements:

• 8-10 years of relevant biotech or pharmaceutical industry experience or strategic consulting; background in market research and forecasting; preference for individuals with in-line product experience; launch experience a plus, Oncology experience a plus.

• Ability to leverage primary/secondary research to develop strategic recommendations.

• Strong market research, forecasting skills.

• Ability to present effectively to executive level leadership.

• Ability to influence peers through data driven logic.

• Ability to professionally communicate and cultivate strong working relationships.

• Excellent verbal and written communication skills.

• Ability to effectively collaborate in a dynamic environment.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• Bachelor’s degree in science/engineering/, MBA preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Senior Finance Manager, Pharmaceutical Operations  

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Finance Manager, Pharmaceutical Operations to serve as the finance business partner to manufacturing, pharmaceutical development, supply chain and the technical operation groups.

Essential duties and responsibilities include but are not limited to the following:

• Provide Finance leadership to business partners.  Work with teams to develop analytics to monitor performance and strategies to keep costs within budget.  Provide updates to senior management on financial performance.

• Work with Pharm Ops department heads to create detailed expense budgets and forecasts.

• Assist with corporate planning exercises – annual budgets, quarterly forecasts, LRP.

• Prepare monthly budget variance analysis and variance explanations for department heads.

• Highlight sensitivities & risks and deliver timely, accurate and granular reporting and explanation of performance, linking business drivers to variances in budget/forecast in Budget Variance Analysis exercise.

• Provide supporting financial analysis to enable R&D leadership to make informed decisions.

• Work with Accounting to help with close activities for manufacturing groups.

• Work with business partners to monitor contracts and invoices to ensure accurate payment and proper coding.

• Assist with financial reconciliations with external partners.

• Identify opportunities to improve business and finance practices and processes.

Requirements:

• 6+ years overall experience in Finance.

• Hyperion Planning/Smartview experience preferred.

• Must have strong analytical, strategic, problem solving skills and solid knowledge of GAAP.

• Experience with inventory accounting, cost accounting and margin analysis strongly preferred.

• Experience in a Pharmaceutical or Biotechnology company supporting Pharm Op's or Manufacturing strongly preferred.

• Independent and proactive self starter who operates with a strong sense of ownership for projects and results who can prioritize work, and handle multiple assignments under tight deadlines and in fast-paced environment.

• Excellent verbal and written communication skills.

• Ability to effectively collaborate in a dynamic environment.

• PC literacy required; Advanced MSOffice skills (Outlook, Word, Excel, PowerPoint). 

Education:

• BA, MBA and/or CPA preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Senior Medical Director, Medical Affairs

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Medical Director, Medical Affairs.  

The Senior Medical Director, Medical Affairs, is responsible for the successful execution of Medical Affairs programs and deliverables through partnership with Medical Science Liaisons, Scientific Communications, Health Economics and Outcomes Research (HEOR), the Clinical Development organization, and others as appropriate.  Additionally, forging productive and compliant partnerships with the Commercial organization and with our Alliance partner, Astellas, is essential.  The candidate will report to the Vice President, Medical Affairs who, in turn, reports to the Chief Medical Officer.

As a leader in the organization, the incumbent will be accountable, along with Medical Affairs leadership, to guide the Medical Affairs program strategy and assure high quality execution of Medical Affairs activities.  The incumbent will also play a key role in the leadership of health economics and clinical outcomes research activities, the establishment and maintenance of key partnerships and collaborations, and the support of opinion leader relationships, both directly, and in conjunction with, the Medical Science Liaison team.

Essential duties and responsibilities include but are not limited to the following:

• Provide leadership to the planning and execution of the Medical Affairs program strategy.

• Support Medical Affairs budget planning and management.

• Maintain high level of expertise on the disease area and serve as key medical resource in the disease area and on specific products.

• Expertly deliver scientific/medical information and clinical/research findings.

• Provide scientific leadership to the ISR Program, including review of proposed IST concepts and protocols, and concepts and protocols submitted by cooperative groups.

• Participate in the design and oversight of corporate-sponsored Medical Affairs trials, including concept and protocol development, with close collaboration with the study teams.

• Provide leadership to the Publications Committee, including review of publications, communications with authors, and participation in the development of the Publication Plan.

• Provide strategic leadership for the Health Economics and Outcomes Research (HEOR) program.

• Provide support for Medical Science Liaison activities.

• Provide Medical expertise to the Commercial organization to compliantly assist in the development and execution of Commercial activities.

• Interface with external experts and health care professionals at major medical conferences, advisory boards, and other external meetings.

• Partner within the Organization to optimize cross-functional communication.

• Support effective coordination of partnership and internal Governance bodies.

• Support high-quality execution of Corporate-wide initiatives.

• Develop, track, execute and report on goals and objectives.

• Be accountable for compliant business practices.

• Provide managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance.

• Other duties as assigned.

Requirements:

• Minimum of 10 years industry experience; oncology experience strongly preferred.

• Strategic and creative thinking.

• Ability to critically analyze research design, methods and outcome measures.

• Successful and superior influencing skills across all levels of the organization and external collaborators.

• Strong problem solving and risk mitigation skills.

• Strong time management and organizational skills.

• Ability to manage multiple projects in a fast paced environment.

• Ability to build working relations throughout the organization and with business partners to achieve business goals.

• Appreciation of diversity and multiculturalism.

• Prior training and experience with Good Clinical Practice (GCP).

• Executive presence.

• Confident, positive attitude, enthusiastic and charismatic.

• Excellent and impactful verbal and written communication skills.

• Values based collaborator – respectful, accountable and collaborative.

• Ability to effectively collaborate in a dynamic cross-functional environment.

• Significant internal interactions, primarily among the different functional teams within Medical Affairs (including Medical Science Liaisons, Scientific Communications and HEOR), Clinical Development and Commercial.

• Minimum of 10 years of experience and demonstrated success within another biotech/ pharmaceutical company, with 7 or more years in Medical Affairs are required.

• Professional knowledge and skills working with oncology and urology therapeutics in prostate cancer is strongly preferred.

• Understanding of Clinical Development and Commercial activities.

• Ability to partner effectively with Field Medical staff is required.

• Working knowledge of applicable Federal and State Compliance guidelines and regulations is required.

• Solid understanding of Health Economics and Product Access through Payers is strongly preferred.

• Experience with partnerships and strategic alliances is preferred.

• Prior experience with vendor selection and management is desired Working knowledge of applicable Federal and State Compliance guidelines and regulations.

• Travel required up to 25%.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• MD degree required, subspecialty and board certification in oncology are preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Associate Medical Director/Medical Director, Medical Affairs  

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Associate Medical Director/Medical Director, Medical Affairs.  

The Medical Director/Associate Medical Director, Medical Affairs is responsible for the successful execution of Medical Affairs programs and deliverables through partnership with Medical Science Liaisons, Scientific Communications, Health Economics and Outcomes Research (HEOR), and the Clinical Development organization.  Additionally, forging productive and compliant partnerships with the Commercial organization and with our Alliance partner, Astellas, is essential.  The candidate will report to the Senior Medical Director, Medical Affairs who, in turn, reports to the Vice President, Medical Affairs.

The incumbent will be accountable, along with the Medical Affairs leadership, for high quality execution of Medical Affairs activities.  The incumbent will also play a key role in the establishment and maintenance of key partnerships and collaborations, and the support of relationships with external experts, both directly, and in conjunction with, the Medical Science Liaison team.

Essential duties and responsibilities include but are not limited to the following:

• Provide support to the planning and execution of the Medical Affairs program strategy.

• Maintain high level of expertise on the disease area and serve as key medical resource in the disease area and on specific products.

• Expertly deliver scientific/medical information and clinical/research findings.

• Provide Medical expertise to the Commercial organization, including review of promotional materials, sales training, and speaker training for promotional programs.

• Plan and execute medical advisory boards.

• Participate in the ISR Program, including review of proposed IST concepts and protocols, and concepts and protocols submitted by cooperative groups.

• Participate in the design and oversight of corporate sponsored Medical Affairs trials, including concept and protocol development, with close collaboration with the study teams.

• Provide support for Medical Science Liaison activities.

• Interface with external experts and health care professionals at major medical conferences, advisory boards, and other external meetings.

• Partner within the Organization to optimize cross-functional communication.

• Support effective coordination of partnership and internal Governance bodies.

• Support high-quality execution of Corporate-wide initiatives.

• Develop, track, execute and report on goals and objectives.

• Be accountable for compliant business practices.

• Other duties as assigned.

Requirements:

• Minimum of 3 years industry experience; oncology experience strongly preferred.

• Strategic and creative thinking.

• Ability to critically analyze research design, methods and outcome measures.

• Successful and superior influencing skills across all levels of the organization and external collaborators.

• Strong problem solving and risk mitigation skills.

• Strong time management and organizational skills.

• Ability to manage multiple projects in a fast paced environment.

• Ability to build working relations throughout the organization and with business partners to achieve business goals.

• Appreciation of diversity and multiculturalism.

• Prior training and experience with Good Clinical Practice (GCP).

• Confident, positive attitude, enthusiastic and charismatic.

• Excellent and impactful verbal and written communication skills.

• Values based collaborator – respectful, accountable and collaborative.

• Ability to effectively collaborate in a dynamic cross-functional environment.

• Significant internal interactions, primarily among the different functional teams within Medical Affairs (including Medical Science Liaisons, Scientific Communications, and HEOR), Clinical Development, Commercial, Regulatory Affairs and Commercial.

• Significant external interactions, primarily with our Alliance partner, Astellas, experts and advocates within the prostate cancer community and payer organizations.

• Minimum of 3 years of experience and demonstrated success within another biotech/ pharmaceutical company, with 1 or more years in Medical Affairs are required.

• Professional knowledge and skills working with oncology and urology therapeutics in prostate cancer are strongly preferred.

• Understanding of Clinical Development and Commercial activities is preferred.

• Ability to partner effectively with Field Medical staff is required.

• Working knowledge of applicable Federal and State Compliance guidelines and regulations is required.

• Solid understanding of Health Economics and Product Access through Payers is preferred.

• Experience with partnerships and strategic alliances is preferred.

• Prior experience with vendor selection and management is desired.

• Working knowledge of applicable Federal and State Compliance guidelines and regulations.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• MD degree required, subspecialty and board certification in oncology are preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

XTANDI Product Manager/Senior Product Manager, Key Customer  

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of XTANDI Product Manager/Senior Product Manager, Key Customer.  

The XTANDI Product Manager, Key Customer, will be an integral part of the marketing team and will be responsible of managing the brands key customer tactics and execution of advisory boards. This position will support the XTANDI Marketing Director, Key Customer, and work closely with the entire marketing team.  They will manage all aspects of peer-to-peer programming, and execution of advisory boards. They will work closely with our collaboration partner, Astellas, on assigned tactics to create a united marketing plan.

Essential duties and responsibilities include but are not limited to the following:

• Manage projects with agency(s) of record for peer-to-peer programming.

• Ensure commercial  KOL interactions are compliant and follow Medivation policy.

• Manage peer-to-peer programming strategy/tactics and align to overall brand strategy.

• Manage KOL commercial interaction plans.

• Provide input on annual brand advisory board plan in collaboration with Astellas execute plan.

• Manage KOL mapping project and update as needed.

• Inform the development of key brand deliverables (e.g., strategic, launch readiness, tactical plans, quarterly business reviews, brand performance updates, etc.) on KOL commercial interactions, peer-to-peer programming and advisory boards.

• Collaborate effectively with the Strategy/Planning and Promotions Directors and Product Managers to maximize brand team effectiveness and realize synergies where possible.

• Partner closely with Finance, market planning and market access to ensure plans maximize brand value.

• Liaise with Astellas counterparts to maximize collaboration and alignment.

Requirements:

• Experience in pharmaceutical or biotechnology marketing or sales.

• Oncology and/or Urology marketing or sales preferred.

• Proven ability to successfully lead/work in a cross functional team setting (clinical, medical affairs, sales, managed markets, regulatory, legal, R&D, project management).

• Demonstrates high ethical and professional standards with business contacts in order to maintain Medivation’s excellent reputation within the biotech community.

• Excellent communication and presentation skills, strong business acumen, analytical orientation, and ability to influence others.

• Experience with a co-development or co-promotion product is a plus.

• Project management, Interpersonal, marketing, leadership, strategic planning and communication skills.

• Self-starter with excellent decision-making capabilities and problem solving skills.

• Adaptable to changing roles/responsibilities required in a fast-paced, rapidly growing company.

• Proven ability to work with cross-functional team members.

• Experience working with collaboration partner preferred.

• Team player.

• Excellent verbal and written communication skills.

• Ability to effectively collaborate in a dynamic environment.

• Significant cross-functional interaction including market strategy and planning, finance, market access, sales and sales training.

• Significant interaction with marketing team from our partner company, Astellas.

• Approx. 35% travel.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• BA/BS required. MBA or advanced degree preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Executive Assistant, Human Resources

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Executive Assistant, Human Resources.

This is a new expansion position created to support the HR leadership in our dynamic and growing Company. The position will directly support the Senior Vice President of Human Resources and the Human Resources leadership team. The position provides a variety of standard administrative support functions. You will also be involved in and help coordinate special projects and department initiatives. The successful incumbent will be self-motivated, have excellent interpersonal skills and the ability to build professional relationships. Individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through is essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.

Essential duties and responsibilities include but are not limited to the following:

• Maintain multiple Outlook calendars and recurring meetings for the department; prioritizing appropriately and using good judgment in offering solutions to complex scheduling and meeting planning as needed.

• Proactively  manage communication (emails, phone calls); screening telephone inquiries, communicating messages, redirecting calls, and appropriately responding to urgent inquiries from company leadership, vendors and other constituencies.

• Provide meeting and event coordination, on and off –site, including reservations and attendee communication, setting up audio and video conference, as well as catering and preparation of meeting and program materials.

• Support and execution of travel activities: prepare and coordinate travel, including accommodations, and compile, submit, and track expenses for the SVP, HR.

• Interface effectively and respectfully with employees and internal and external contacts.

• Handle highly confidential information and documentation appropriately and effectively.

• Establish, update and maintain departmental files, inventories, and records (paper and electronic, and other platforms as needed).

• Generate and compose confidential, routine and non-routine documents. Proof read documents and materials and correct as necessary and/or composes routine correspondence using predetermined formats.

• Provide clerical support as necessary, including filing, faxing, copying, collating, and shipping.

• Order and maintain department supplies and equipment.

• Serve as a collaborative and thought partner to the department. Be a team player and support colleagues as needed.

• Track and facilitate contract renewals of Executive and department memberships.

• Create binders, folders and labels to proactively organize, retain Executive records.

• Determine innovative and creative as well as time-tested methods and procedures for duties and assignments and provide support and guidance to other nonexempt personnel.

• Other duties as assigned.

Requirements:

• A minimum of 8 years of administration experience, preferably in a life sciences, biotechnology (or other high-tech), pharmaceutical, health care or other service sector company environment.

• Daily demonstrates a positive, ‘can do’ and service oriented attitude.  Strong oral and written communicator; detail-oriented with a commitment to accuracy.

• Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.

• Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.

• Ability to multi task and shift priorities quickly while working under tight deadlines.

• Must have excellent customer-service orientation, high degree of professionalism, and ability to work limited direction; strong team player.

• Skilled in developing collaborative internal and external relationships.

• Required skill in the operation of standard office equipment including: fax machines, copy machines and other equipment as necessary.

• Excellent verbal and written communication skills.

• Ability to effectively communicate, collaborate and deliver an excellent work product in a fast paced, and rapidly growing dynamic company.

• Ability to present themselves in appearance and conversationally  in a professional manner.

• Interacts with Medivation employees, visitors, candidates for employment and vendors.

• PC wizard with a strong demonstrated proficiency in MSOffice (Outlook, Word, Excel, PowerPoint) Visio.  Workday experience desirable.

Education:

• High school diploma, GED, secretarial/business school certificate.

• College degree, or equivalent experience, desired.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity 

Senior Manager, Organization & Talent Development

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Manager, Organization & Talent Development.

This role in partnership with the Director, Organization & Talent Development works collaboratively with HRBPs and business leaders to assess client needs, identify issues, and design and implement appropriate organization and talent development solutions.  This role will also support engagement initiatives emerging from the annual employee engagement survey.  The work is focused on assessing and delivering organizational change and development solutions that support rapid growth and company success.

Essential duties and responsibilities include but are not limited to the following:

Organization & Talent Development support to include:

• Deliver the company’s core talent initiatives and activities within client groups including on-boarding, annual performance management cycle, talent review and succession planning, engagement and recognition initiatives, and professional and HR compliance development in support of MDVN’s Core Values and Culture.

• Design and facilitate targeted organizational & talent development programs as needed, e.g. manager assimilation, team-building, leadership development, effective communication, etc.

• Partner with Dir. OD & Talent Development to conduct data analysis and interpretation to build a development strategy that will enable rapid company growth and success.

• Provide change management support to help plan and implement rapid change initiatives that demonstrate tactical and people adoption.

• Design and facilitate leadership meetings that assist with effective issue resolution and goal attainment.

• Develop engaging and professional training materials using traditional, web and social technologies.

• Assist with internal employee communications across various media platforms, including maintaining the HR SharePoint employee portal.

HR Generalist support to include:

• The role must utilize independent judgment to assess, innovate, improve and develop human resource programs, policies, and procedures to support employees at all levels.

• General human resource knowledge in talent acquisition compensation, employee relations, benefits, etc.

• This role in conjunction with HR leadership will support HR project work.

Requirements:

• Minimum 8 years’ experience in Corporate HR, OD and/or Learning role.

• Experience with Cornerstone or other LMS.

• Experience influencing and coaching others.

• Demonstrated ability to research, evaluate and recommend best practices in the execution and delivery of talent develop programs and manage all aspects of the implementation of the programs and their effectiveness.

• Previous experience in Biotech, Pharmaceutical or Life Sciences preferable.

• The role must utilize independent judgment to assess, innovate, improve and develop programs and interventions to support employee and company success at all levels.

• Vendor management including contract administration and accountability.

• Proven experience handling highly confidential and sensitive personnel information.

• Proven facilitation, training and presentation skills.

• Organized, detail oriented, and self-motivated to work in a rapidly changing environment.

• Flexible with the ability to demonstrate understanding, respect and appropriate challenge at all levels of the organization from executive leadership to individual contributor.

• Comfortable dealing with ambiguity and resistance.

• Understanding and application of adult learning principles.

• Intermediate knowledge of SharePoint.

• Use a range of analytical tools, personal experience and business understanding to generate compelling insights.

• Skilled in developing collaborative internal and external relationships.

• Excellent follow through.

• Strong knowledge of Cornerstone or other LMS platform.

• Ability to work and thrive in a fast-paced environment.

• Detail-oriented with superb organizational skills.

• Strong written and verbal communication skills.

• Ability to manage multiple responsibilities with tight deadlines.

• Positive, ‘service oriented’ attitude; always willing to learn.

• Strong analytical/technical skills.

• Comfortable with project management.

• Proficient in MS Office (Excel and Word).

• Effective interpersonal and communication skills. 

• Ability to effectively communicate and share knowledge with internal and external contacts at all levels.

• Skilled in developing collaborative internal and external relationships.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint, Visio) , LMS. 

Education:

• Bachelor’s Degree or equivalent experience in an organizational development or learning function. 

• Master’s Degree in HR or Organizational Development desirable.

• SPHR or PHR desirable.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity 

Senior Manager, Supply Chain Process Improvement

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Manager, Supply Chain Process Improvement.

The Sr. Manager is responsible for oversee Supply Chain Road map portfolio of process improvement and system implementation projects.  Lead critical projects to build saleable clinical supply and establish commercial supply network.  Works within the Supply Chain organization as well as cross functionally with peers to maintain consistent practices what enable a robust and efficient supply chain.  Has a front-to-end knowledge of supply-chain best practices (plan, source, make, deliver), ERP systems, as well as experience working within a cGMP environment.

Essential duties and responsibilities include but are not limited to the following:

• Oversee process improvement Road map for clinical and commercial supply. 

• Monitor project statuses and provide updates to management.

• Lead several projects critical to building saleable clinical supply and establish commercial supply chain.

• Provide guidance and mentor team members on process improvements.

• Act as key liaison with IT for implementation of new systems.

• Act as key team member in Oracle ERP implementation and oversee creation of MDM, BOMs, and specs.

• Other activities as required.

Requirements:

• 8+ years min work experience.

• •5+ experience working in a Clinical/Commercial Supply Chain process improvement role or consulting experience.

• Supply Chain Knowledge: has an advanced understanding of groups within supply and key stakeholders.  Understands interdependencies of parts of supply chain and has an advanced understanding of supply chain strategy and concepts.  Uses industry knowledge to drive of best-practices within team.

• Analytical Skills: collects and analyzes data to support work and make recommendations.  Determines methodology analysis and presents data in compelling manner.

• Business Process Re engineering: identifies change opportunities and uses process improvement methodologies to lead process changes.  Knowledgeable about change management to addresses resistance change and ensure successful project implementation and adoption.

• Project Management: drives projects/process improvements within Supply Chain and internal/external stakeholders.  Determines deliverables, milestones, and timeline goals.  Takes accountability over tasks, pushes team members to achieve goals, and works to resolve issues prior to escalation.  Acts as mentor on projects lead by more junior team members.

• Financial Acumen: has a good understanding of budgeting, inventory costs, cash cycles, S&OP processes.  Looks to optimize costs across all supply chain functions.  Uses financial data to make better informed decisions.

• Strategy: understands how role supports the supply chain strategy. Understands how supply chain supports Medivations objectives.

• Written/verbal: strong communication skills, delivers clear messages, and adjusts communication to audience.

• Collaboration/Teaming: works collaboratively with peers and stakeholders.  Looks to break silos and ensure timely and accurate flow of information.

• Networks: builds and leverages strong network with stakeholders.

• Leadership: Sets example for team members on job tasks, competencies, and communication/team skills.  Leads work across organization with peers and stakeholders.  Takes accountability and drives accountability of stakeholders

• Experience in project management and process improvement methodologies (e.g. SCOR, Six Sigma).

• Front-to-end supply knowledge.

• Experience with ERP systems.

• Working knowledge of IRT systems.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint, MSProject).

• Working knowledge of supply-chain in ERP and non-ERP environments.

• 10% travel.   

Education:

• BS in science area, business administration, finance, or technical field.

• Advance degree preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity 

Director/Associate Director, Pharmaceutical Technology

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Director/Associate Director, Pharmaceutical Technology.

The Assoc. Director/Director of Pharmaceutical Development will lead the Drug Product development for novel small molecules from discovery to commercialization. The primary responsibility includes preformulation, material sciences, clinical formulation development, commercial drug product and process, and technology transfer to commercial manufacturing.  He/She will provide strategic direction, tactical oversight and technical expertise for all activities within the pharmaceutical development area within Small Molecule Technical Operations and will play a key role in post launch manufacturing trouble shooting and change management.

Essential duties and responsibilities include but are not limited to the following:

• Provide leadership, vision, and management to the Small Molecule Pharmaceutical Development organization.

• Become a member of leadership team for the Small Molecule Technical Operation and participate in strategic decisions relating to portfolio, organization, processes, budget and culture within the department.

• Effectively apply expertise in preformulation, material sciences, formulation development and overall drug development.

• Have knowledge of GMP regulations, ICH guidance and current regulatory expectations.

• Define a science-driven and risk-based pharmaceutical development strategy to deliver projects from discovery, clinical development to commercial production, and incorporating QbD, DOE approaches and computational modeling and simulation.

• Responsible for technology transfer, strategic planning, budget management, departmental integration within the Small Molecule Pharmaceutical Development.

• Establish an effective departmental infrastructure and system to enable efficient preclinical and clinical formulation development and technology transfer by leveraging internal and external expertise and capability (laboratory design and purchasing, development of operating procedures, documentation systems).

• Manage budgetary, regulatory, and compliance systems within the framework of an internal/outsourced development and manufacturing business model.

• Evaluate and implement new technologies and practices internally and through CROs/CMOs, and be familiar with current industry best practices.

• Establish a comprehensive knowledge management system to capture critical raw data, analytical development activities, knowledge and to manage change control.

• Provide critical assessment from Small Molecule Analytical Development during due diligence of external opportunities and capabilities.

• Routinely interface with other departments, such as Process Chemistry, Analytical Development, Quality Assurance, Quality Control, Regulatory, Biologics Technical Operations, Supply Chain, Early Development, and Project Management.

• Develop appropriate training for technical, GMP and safety.

Requirements:

• Requires 15+ years of progressive experience in the biopharmaceutical/biotech industry, GMP environment.

• Deep knowledge of modern pharmaceutical practices and techniques and solid scientific knowledge of pharmaceutical sciences and a good understanding of the drug development process. 

• Experiences and deep understanding solid dosage formulation development and manufacturing is requirement, and experiences in parenteral formulation development and manufacturing is preferred.

• Significant experience working in an outsourcing environment as well as building internal laboratories.

• A strong track record of scientific achievements including external publications and presentations.

• Proven record of building and leading a team.

• Strong leadership skills and effective ability to influence.

• Candidates should have advanced problem solving skills, strategic thinking, proven leadership, process optimization experience and outstanding written and verbal communication skills.

• Approximately 20-30% level of travel may be needed for the interactions with CMOs or CROs for critical project activities, and for representing Medivation to present and/or participate in professional conferences.

• Working in normal office working environment and attending internal and external meetings.

• Thorough understanding of the product development and pharmaceutical development for small molecules.

• Ability to interpret and communicate information both internally and to external suppliers.

• Ability to prioritize, manage multiple tasks, and meet deadlines.

• Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices.

• Excellent interpersonal and leadership skills and abilities.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• Ph.D. degree in Pharmaceutical Sciences, Pharmaceutical Technology, Chemical Engineering and related fields.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity 

Senior Specialist/Manager, CQA Operations

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Specialist/Manager, CQA Operations. This position’s main responsibility is to support internal Study Management Teams, conduct internal and external GCP audits and to support internal Quality Assurance activities. 

Essential duties and responsibilities include but are not limited to the following:

• Conduct document reviews and audits of protocols, informed consents, clinical study reports, Investigator Brochures, regulatory submission documents, and other essential study documents as assigned.

• Conduct data reviews and audits of patient data listings.

• Support/Lead the Quality Assurance group at clinical team and cross-functional clinical development  Study Management Team meetings.

• Support/Lead GCP audits of clinical investigator sites, vendors, databases, clinical laboratories, systems and processes.

• Provide support to regulatory inspection readiness activities and internal audits of company systems and processes.

• Lead the evaluation of GCP activities, policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.

• Lead Clinical Quality Assurance (CQA) investigations, CAPA’s and Incident Reports.

• Provide CQA training as assigned.

• Other duties as assigned.

Requirements:

• 4-5 years of experience in biotech/pharmaceutical or related area; GXP and GCP experience; or equivalent combination of education, training and experience.

• Knowledge of ICH-GCP and appropriate regional clinical research regulations and guidelines.

• Strong problem solving, risk assessment and impact analysis abilities.

• Flexible and able to multi-task and prioritize competing demands/work load.

• Excellent verbal and written communication skills.

• Ability to effectively collaborate in a dynamic environment.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint). 

Education:

• Bachelor of Science degree.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Commercial Operations Manager/Senior Manager, Aggregate Spend

Medivation, Inc. (NASDAQ: MDVN—www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of Commercial Operations Manager/Senior Manager – Aggregate Spend/Contracting.

The Commercial Operations Manager/Senior Manager will assist in advancing the design and effectiveness of the US aggregate spend program as well as lead its day-to-day operations under the guidance of the Commercial Operations Department and Healthcare Compliance Department.

Essential duties and responsibilities include but are not limited to the following: 

• Primary responsibilities include the following:

• Develop procedures and tools to assist commercial employees in complying with policies created by Healthcare Compliance.

• Collaborate with IT and vendors to enact system changes for reporting of information or for education purposes

• Develop and deliver topical training and communications based on established and new requirements relating to federal and state marketing disclosure laws for Commercial as well as changes to internal policies.

• Serve as a resource to external third party stakeholders (e.g., HCPs and vendors) that may be impacted by Medivation’s federal and state marketing and disclosure reporting obligations.

• Stay abreast of and track relevant federal and state marketing disclosure laws and advise internal stakeholders on applicability to Medivation’s operations.

• Assist Healthcare compliance with preparation and submission of Medivation’s annual disclosure and compliance program certification reports as required under federal and state marketing and disclosure laws.

• Serve as primary point of contact for any questions or requests from internal stakeholders relating to the aggregate spend program or federal and state marketing and disclosure laws for Commercial.

• Assist in the architecture design, management and oversight of all processes and organizational inputs as they relate to Medivation’s aggregate spend program.

• Work cross-functionally with internal and external stakeholders (e.g., vendors) to maintain and continue to enhance policies, procedural documentation, process flows, and training materials relating to Medivation's aggregate spend program.

• Analyze aggregate spend data to identify compliance and competitive intelligence trends and prepare reports for internal stakeholders.

• Proactively identify data integrity issues, assess root causes and manage implementation of appropriate corrective actions.

• Coordinate execution of aggregate spend program internal and/or external audits.

• Other duties may be assigned.

Requirements:

• Four years’ experience in a US pharmaceutical or medical device healthcare compliance setting.

• Experience implementing compliance program-related policies, procedures, and controls related to federal and state marketing and disclosure laws.

• Excellent analytical, investigative, project management, and communication skills and the ability to work with large amounts of data and distill key points to internal stakeholders.

• Strong ability to evaluate plans, policies, and procedures to identify gaps as they relate to emerging regulations or evolving company needs.

• Excellent written communication skills with an emphasis on policies and procedures, business process documentation, and Powerpoint presentations.

• Seeks to encourage cross-functional communication and partnership with colleagues in order to achieve compliance and business objectives.

• Ability to prioritize in a rapidly changing environment and multitask various projects.

• Strong commitment to compliance, ethics and accountability.

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• MS Office skills (Outlook, Word, Excel, PowerPoint).

• Excellent verbal and written communication skills

• Ability to effectively collaborate in a dynamic environment

• This job requires a combination of analytical, organizational and interpersonal skills.

• Ability to work independently with minimal guidance.

Education:

• BA/BS with 8 years’ experience; equivalent combination of advanced degree and less experience may be considered.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Clinical Trial Disclosure/Transparency Lead 

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Clinical Trial Disclosure/Transparency Lead.

The position’s primary purpose is to oversee all activities related to clinical trial disclosure to ensure compliance with all applicable international laws, regulations, and internal policies.   

Essential duties and responsibilities include but are not limited to the following:

• Plan, organize, oversee, and manage all information required to be posted to public registries such as ClinicalTrials.gov, EudraCT, and international registries. 

• Proactively identify and resolve issues to ensure compliance of disclosure.

• Act as administrator and oversee ClinicalTrials.gov and EudraCT accounts for all company sponsored studies. 

• Develop initial study posting and results postings in accordance with internal SOP. 

• Update postings as new clinical sites are added to posted studies and update as status changes. 

• Serves as point of contact for quality assurance reviewers from ClinicalTrials.gov and outside inquiries related to clinical trial disclosure.

• Obtain appropriate internal and business partner review and approval of postings.

• Keep informed of current registry requirements.  Monitor foreign registries and industry trends. 

• Develop and maintain registry processes to optimize efficiency, ensure quality, and promote continuous improvement. 

• Serve as subject matter expert on clinical trial disclosure and provide ongoing guidance to internal staff, study teams, and senior management.

• Develop and provide regular reports of metrics related to tracking and monitoring clinical trial transparency activities.

• Oversee consultants and vendors as appropriate.

• Other duties as assigned.

Requirements:

• 4+ years in clinical R&D.

• Experience in clinical R&D, preferably in medical writing, medical publications, regulatory affairs, trial management, or equivalent; ideally in an international work environment.

• Superior skills in document processing, review, and approval procedures.

• Comprehensive knowledge of ICH GCP, FDA, EMA, and other international regulations related to clinical trial disclosure and responsible data sharing.

• Able to work independently and with good time management skills.

• Analytical thinker with good decision making ability.

• Able to identify risks and develop mitigation strategies; anticipate and resolve issues in complex or sensitive situations.

• Excellent verbal and written communication skills.

• Able to collaborate effectively in a dynamic environment.

• Foster cross functional cooperation and alignment internally and with business partners.

• Work closely with the Clinical Development organization, Medical Affairs, Regulatory Communications, Regulatory Affairs, Biometrics, Legal, and other cross functional members across the company and with external service providers as needed.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• Degree in life science or medicine preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Manager, SDTM Programming

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Manager, SDTM Programming. The Manager SDTM Programming will work in Medivation’s SDTM Programming group across Therapeutic areas. The candidate will be responsible for leading and managing the SDTM development, validation and infrastructure. 

Essential duties and responsibilities include but are not limited to the following:

• General SDTM mapping skills:

• • 1) Identify required domains based on CRF/external data.

  • 2) Define and develop mapping/programming specifications per study requirements.

  • 3) Understand the usage of CDISC Metadata Submission Guidelines for CRF annotation.

• In-depth technical knowledge of SDTM including SDTM mapping strategies and conventions including Controlled Terminology.

• Experience and expertise across different versions of SDTM and associated implementation guides.

• Experience and expertise with Oncology and other therapeutic area conventions.

• Develop SDTM standard dataset specifications and follow specifications to create SDTM datasets (as needed).

• Knowledge of DEFINE-XML and Reviewer’s Guides.

• Knowledge of CDASH and end-to-end data standardization.

• Serve as technical lead and project manager for multiple studies managing all aspects of SDTM study deliverables related to statistical and clinical programming as needed.

• Represent the SDTM team at Study Management Team and Clinical Development meetings to address deliverables and timelines.

• Manage multiple contractors and FTEs.

• Address contractor and FTE performance evaluations, training and mentoring.

• Address resourcing to adequately staff projects as needed.

• Assist in the review of key study-related documents produced by other functions, e.g. SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans and other clinical documents as related to SDTM.

• Interact and communicate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing and Medical Monitors to address programming related study deliverables.

• Write, test and validate SAS programs to produce SDTM datasets and associated deliverables (aCRF, define.xml, SDRG).

• Understand and execute department-, product- and study-level macros and utilities. Write, test and validate product- and study-level macros and utilities to enable efficient domain development.

• Be technical resource for programming group to provide advice on complex programming tasks and/or standards.

• Contribute to the continuous improvement of SDTM process.

• Assist in the development review of Statistical Programming policies, standard operating procedures and other controlled documents.

• Provide support to and mentor other programmers and contractors.

• Interface with outsourcing partners and vendor.

• Provide managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance.

• Other duties as assigned.

Requirements:

• 8+ years clinical programming experience using SAS (Manager).

• Expert level SAS programmer with experience in delivering on complex programming assignments and analysis.

• Expert level knowledge and extensive hands-on experience of CDISC methodologies and SDTM mapping.

• Involvement with CDISC or PhUSE working group is a plus.

• Experience in Oncology Trials a plus.

• Experience in FDA/EMEA trial and regulatory submissions a plus.

• Strong SAS programming skills to manipulate/restructure data and implement coding algorithms and logic.

• Computer programming using SAS and expertise in using SAS Statistical and Reporting Procedures.

• Understanding of computer operating systems, word processors, document applications.

• Fundamentals of project planning and management.

• Drug development process.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• Bachelors or Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity 

Clinical Study Assistant

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Clinical Study Assistant.

The successful candidate will have the skills necessary to thrive in a dynamic and growing company environment, as he/she assists Clinical Research staff in the conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials. Particularly important skills include flexibility; logical thinking; ability to prioritize day-to-day and critical tasks; willingness to adapt quickly to changing business conditions and learn new skills; interpersonal and team building skills.

Essential duties and responsibilities include but are not limited to the following:

• Prepare, collect, review and track study Trial Master File (TMF) documents and submit to central records for storage.

• Perform on-going review of the TMF to ensure files are properly maintained, stored and archived.

• Track approval of essential study documents; assist in tracking and assembling documents required for submission to Regulatory Affairs.

• Assist with project tracking including entry and maintenance of clinical study details in Medivation’s Clinical Trial Management System (CTMS).

• Create and maintain documents, tables, databases, spreadsheets and files as needed, in support of clinical trial operations.

• Assist Clinical Trial Managers (CTMs) or other Clinical Study Assistants (CSAs) in the preparation of study binders, contact lists, site manuals and other study tools and templates, as directed.

• Assist in management and distribution of clinical study supplies and equipment, including purchase and assembly, shipping, and maintenance of inventory, as directed.

• Prepare drug supply transmittals, track drug supply, and make appropriate arrangements for returned drug for clinical projects, as needed.

• Provide reports and information to staff members concerning clinical and non-clinical supply issues.

• Participate in meetings, including scheduling, generation and distribution of meeting agendas and minutes.

• Work with vendors, Contract Research Organizations (CROs), and Medivation team members to meet clinical study goals and timelines.

• Other duties as assigned.

Requirements:

• Limited (~ <2 years) pharmaceutical company experience or prior clinical study assistant experience.

• Basic knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials.

• Proficiency with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems.

• Must be self-motivating and be able to follow directions precisely, prioritize and manage a large volume of work, handle a moderate amount of pressure, and show attention to detail.

• Strong interpersonal skills and professional attitude are essential as this individual interacts with many people of varying levels of responsibility for clinical studies and business performance.

• Excellent verbal and written communication skills.

• Ability to effectively collaborate in a dynamic environment.

• Must be able to write clearly and summarize information effectively.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

• Prior experience in Biotechnology/Pharmaceuticals is a plus.

• May travel <5% for site visits and training.

Education:

• BS/BA in Life Science or related discipline.

• Licenses or Certifications: Clinical Research certification preferred, but not required.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Drug Safety Manager (Contract)

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of Drug Safety Manager (Contract).

Medivation is focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation’s goal is to transform the treatment of these diseases and offer hope to critically ill patients and their families. With the approval of Xtandi (enzalutamide) capsules in late August and the early September product launch immediately following, Medivation is in the process of building and developing a world-class workforce to take the company to the next strategic level.

The Manager of Drug Safety will independently support the Drug Safety Department.  The Manager of Drug Safety will work in a role of leadership in development, implementation and maintenance of a quality system for all Drug Safety activities, encompassing processes, procedures, compliance and metrics.

Essential duties and responsibilities Include but are not limited to the following:

• Process SAE and AE reports of marketed and investigational products in accordance with all applicable regulations, guidelines, and SOPs with little or no supervision.  This includes detailed review of source documentation, assessing cases for reportability, accurate data entry, and quality check.

• Maintain regulatory and department compliance by ensuring timely completion of reports and facilitating submissions of reportable cases to regulatory agencies, study investigators, licensing partners and CROs.

• Represent the Drug Safety Department in cross-functional team meetings.

• Conduct periodic reconciliation of SAEs between the drug safety and clinical trial databases for ongoing clinical studies.

• Participate in the preparation of aggregate safety reports, such as quarterly safety reports to Ethics Committees and annual reports to regulatory authorities.

• Draft and update departmental SOPs and other work practices as assigned and maintain consistency with regulatory guidelines and good pharmcovigilance practices.

• Participate in regular audits of department SOPs with guidance from the (Director), participate in training of drug safety staff and internal and external audiences on drug safety related topics, such as investigator meetings.

• Evaluate project case workflow and offer solutions for process improvement.

• Maintain a high level of understanding of federal and international regulations and guidances so as to guide departmental policies and procedures.

• Lead team members, e.g., Drug Safety Coordinators, Drug Safety Associates and Senior Associates, to facilitate efficient case processing.

• Provide mentorship to DSAs and Senior DSAs in day to day case processing activities.

• Draw upon the knowledge of Drug Safety regulations & practices, disease specific clinical knowledge and understanding of corporate objectives to solve complex problems in creative and effective ways as well as to anticipate routine problems and mitigate them without supervisory intervention.

Requirements:

• Minimum of 6 years of relevant experience which includes 4 years in drug safety.

• Broad knowledge of domestic and international drug safety regulations, industry practices and standards.

• Must have a strong attention to detail, teamwork and initiative.

• Must have excellent written and oral communication skills, resourcefulness and personal organization skills.

• Excellent working knowledge of MedDRA and WHODRUG coding dictionaries.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• BS degree in a life science discipline, e.g., pharmacy, nursing.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Director/Associate Director, Health Economics & Outcomes Research

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of Director/Associate Director, Health Economics & Outcomes Research.

The Director/Associate Director, Health Economics and Outcomes Research (HEOR), is responsible for the successful execution of HEOR programs and deliverables through partnership with Medical Affairs (including Medical Science Liaisons and Scientific Communications), and the Clinical Development organization.  Additionally, forging productive and compliant partnerships with the Commercial organization and with our Alliance partner, Astellas, is essential.  The candidate will report to the Senior Director, HEOR who, in turn, reports to the Vice President, Medical Affairs.

The incumbent will be accountable, along with HEOR leadership, for high quality execution of HEOR activities.  The incumbent will also play a key role in the establishment and maintenance of key partnerships and collaborations, and the support of relationships with external experts, both directly, and in conjunction with, the Medical Science Liaison team.

Essential duties and responsibilities include but are not limited to the following:

• Support the planning and execution of the HEOR program strategy.

• Design, implement, and manage outcomes research projects including, but not limited to, retrospective database analyses, economic models, AMCP dossiers and chart reviews.

• Develop payer value strategies in collaboration with Medical Affairs and Market Access teams.

• Design, conduct, analyze, and report HEOR studies including observational and interventional studies, cost-effectiveness studies, budget impact studies, and retrospective. database studies to generate appropriate evidence to support current market needs and life cycle planning.

• Provide HEOR input into the design of corporate sponsored trials and other trials with HEOR endpoints.

• Develop HEOR training and presentation materials for Medical Affairs and other teams as appropriate.

• Maintain high level of expertise on the disease area and serve as key HEOR resource in the disease area and on specific products.

• Remain current on new clinical and HEOR evidence for product portfolio and key competitors.

• Present information about Medivation’s products to payer organizations.

• Collaborate with external experts in the development and implementation of health outcomes educational programs or collaborative research initiatives.

• Interface with external experts and health care professionals at major medical conferences, advisory boards, and other external meetings.

• Manage relationships with vendors to ensure timely and on-budget completion of high quality projects.

• Partner within the Organization to optimize cross-functional communication.

• Support effective coordination of partnership and internal Governance bodies.

• Support high-quality execution of Corporate-wide initiatives.

• Develop, track, execute and report on goals and objectives.

• Support budget planning and management.

• Be accountable for compliant business practices.

• Other duties as assigned.

Requirements:

• At least 5 years of HEOR experience in the pharmaceutical industry; oncology experience strongly preferred.

• Experience in managing multiple projects across a variety of HEOR methodologies and therapeutic areas.

• Experience with partnerships and strategic alliances is preferred.

• Strategic and creative thinking.

• Ability to critically analyze research design, methods and outcome measures.

• Successful and superior influencing skills across all levels of the organization and external collaborators.

• Strong problem solving and risk-mitigation skills.

• Strong time management and organizational skills.

• Ability to manage multiple projects in a fast paced environment.

• Ability to build working relations throughout the organization and with business partners to achieve business goals.

• Appreciation of diversity and multiculturalism.

• Prior training and experience with Good Clinical Practice (GCP).

• Confident, positive attitude, enthusiastic and charismatic.

• Excellent and impactful verbal and written communication skills.

• Values based collaborator – respectful, accountable and collaborative.

• Ability to effectively collaborate in a dynamic cross-functional environment.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• Advanced Scientific Degree (PhD, MD, PharmD).

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity, M/F/D/V

Administrative Assistant -  Multiple Openings

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of Administrative Assistant  - Multiple Openings.

The Administrative Assistant position provides a variety of standard administrative support functions. Individual must be self-motivated, have excellent interpersonal skills and the ability to build professional relationships. Individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through is essential for this job.

Essential duties and responsibilities include but are not limited to the following:

• Setting up conference calls, often involving internal personnel and/or external parties, and possibly encompassing the use of audio and web-based meeting technologies.

• Maintaining day-to-day calendar and recurring meetings for the department.

• Providing meeting coordination and support to team members as required; act as a central contact for the development team for designated project communications, correspondence and associated documentation.

• Schedule meetings and arrange on site and off site meetings, including catering services.

• Prepare and coordinate travel and expense report management, including accommodations, domestic and international.

• Compile, submit, and track expenses for the Senior level staff.

• Participate in recruiting efforts by working with the human resources department to schedule interviews, coordinate interview packets and host the candidate. Participate in on-boarding activities.

• Assist with contract document preparation.

• Prepare agendas and make arrangements for departmental, company and partnered team meetings.

• Interface effectively with employees and external contacts at all levels.

• Oversee and execute timely completion of additional projects, as needed.

• Handle confidential material effectively and discreetly.

• Establish, update and maintain departmental files (paper and electronic), inventories, and records.

• Screen telephone calls, take messages, redirect calls, and respond to routine inquiries regarding department business.

• Provide clerical support as necessary, including filing, faxing, copying, collating and all other administrative support.

• Type and format confidential and non-routine documents.

• Proof work and make changes as necessary and/or composes routine correspondence using predetermined formats.

• Prepare and send outgoing FedEx correspondences.

• Maintain department supplies and equipment.

• Serve as a collaborative member of the organization’s administrative team and offer relief support, as needed.

Requirements:

• A minimum of 3 - 5 years of experience in progressively increasing positions of responsibility.

• Biotech/Pharmaceutical industry experience preferred.

• Proven experience handling confidential and sensitive information.

• Strong knowledge of MS Office (Excel, Word, PowerPoint, Outlook).

• Excellent analytical, planning and organizational skills with strong attention to detail.

• Ability to effectively communicate and share knowledge with internal and external contacts at all levels.

• Skilled in developing collaborative internal and external relationships.

• Ability to multi task and shift priorities quickly.

• Excellent and timely follow through.

• Proven ability to work under tight deadlines and pressure in a composed manner.

• Must have excellent customer-service orientation, high degree of professionalism, and ability to work with little or no direction; strong team player.

• Ability to learn quickly and take on new challenges as they arise.

• Must be flexible, resourceful, and detail oriented.

• Effective interpersonal and communication skills. 

• Interacts with Medivation employees.

Education:

• High School diploma or GED.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity, M/F/D/V

Recruiter, Talent Acquisition (Contract)

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Recruiter, Talent Acquisition (Contract). 

The Talent Acquisition Recruiter is responsible for implementing the organization’s recruitment plan by identifying and recruiting qualified candidates for open approved requisitions. The selected candidate will provide expert level consultation, guidance and direction in sourcing and recruitment to the Director of Talent Acquisition and Hiring Managers.  Also, provide in-depth content expertise of development and/or implementation of sourcing and recruitment programs, policies and practices. The Recruiter ensures the ongoing and future organizational talent demands are met while ensuring employment policies and practices are compatible with all federal and state employment laws.

Essential duties and responsibilities include but are not limited to the following:

• Identify and source qualified talent for current open roles, Source, cold call, build relationships and network to generate successful placements.

• Manage the full-cycle recruitment process, including initial applicant sourcing, qualification assessments, interviews, and offers.

• Work with Director, Talent Acquisition and hiring managers to optimize recruitment efforts.

• Assist in the development and implementation of recruitment strategy, including job posting optimization, recruiting marketing channel development, job board procurement, digital and non-digital employment marketing, comprehensive recruitment campaign planning, talent planning, etc.

• Be familiar with future talent needs and proactively recruit and source; develop talent pool for anticipated growth.

• Use social media, job boards, Internet sourcing, and other technical means to source applicants for open jobs.

• In conjunction with Director of Talent Acquisition, prepare and negotiate job offers and relocation benefit packages where applicable.

• Partner with Compensation team to assure accurate salary data for open positions.

• When necessary, engage external recruitment resources to compliment internal recruitment strategy.  Assist in the evaluation and provide feedback regarding vendor quality, compliance and service.

• Use applicant tracking systems and other recruiting software to track applicants through the selection phase through on-boarding.

• Implements the AAP/EEO/M/F/H in a manner consistent with Federal, State, local and company compliance polices and requirements.

• In conjunction with HR management and hiring managers assures that Job Descriptions are updated and current, reflecting the essential functions and requirements of each position being recruited.

• Stays current and is innovative in effective sourcing practices. Works with staff to utilize resources in a cost effective quality, and timely manner. 

• Strong partnership and in-depth understanding of the business and current projects and challenges.

• Develops and reviews necessary updates to written recruitment and selection procedures and materials on the web and other communications to hiring management.

• Performs related duties as required. 

Requirements:

• 3+ years of full cycle recruiting experience.

• Must have excellent customer focus, communication and negotiating skills, and a track record of executing key strategic initiatives.

• Ability to identify and understand issues and use effective approaches for developing solutions, understanding facts, constraints and bringing issues to closure.

• Proficient with resume tracking and database programs, Workday HRIS preferred.

• Proficient use of computers, general office applications, and fluent with Microsoft Word, Excel, and Outlook.

• Solid understanding and knowledge of the Pharmaceutical industry is preferred along with exposure to policies, procedures, Federal/State legislation as it impacts Employment Law and general HR Administration.

• Detail-oriented, action/goal-oriented, follow through and drive projects to timely completion.

• Demonstrate strong organizational skills, good judgment.

• Excellent written and verbal communication skills.

• Must be able to work independently as well as work in a team-oriented and fast paced environment .

Education:

• Bachelor degree or 3+ years of full cycle recruiting experience.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity, M/F/D/V

Senior Analyst, Clinical Systems    

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Analyst, Clinical Systems.  

The Senior Analyst of Clinical Systems will support the lifecycle management of various clinical systems with a focus on CTMS (Clinical Trial Management System).  Lead clinical systems project initiatives with other functional groups within Clinical Development. Support the development and maintenance of GxP systems through proper validation documentation per 21 CFR Part 11.  Support and manage tier -1-3 level of application support as well as manage vendor support and project activities. Administration and support for various Clinical Systems, including but not limited to the IRT (Interactive Response Technology), and eTMF (Electronic Trial Master File).

Essential duties and responsibilities include but are not limited to the following:

• Manage the administration of activities for Clinical Operations Systems (User Management, Change Management, SDLC).

• Provide tier 1-3 level user support for Clinical Operations Systems.

• Manage the development and maintenance of documented processes related to the use of Clinical Systems.

• Manage the development of clinical reports (SharePoint, SSRS, SQL).

• Manage clinical systems project initiatives through charter from requirements, development, and testing of validation documentation. 

• Support Clinical Systems integrations, and upgrade activities with QA, IT, and Clinical Development.

• Oversee the development of clinical solutions incorporating proper testing, and execution of SDLC documentation.

• Manage vendor relationships.

• Other duties as assigned.

Requirements:

• Prior experience with Clinical Systems (CTMS, SharePoint, eTMF, IRT).

• 3-5 years of experience in clinical research environment and understanding of clinical terminology and SDLC process.

• Experience with or understanding of clinical trial related documentation. 

• Excellent technical skills and proficiency in working with databases.

• Detailed understanding of clinical trial operations and regulations (GxP, CFR 21 Part 11).

• Understands and manages clinical systems under SDLC processes.

• Must be self-motivating and be able to follow directions, prioritize and manage a large volume of work.

• Must be able to handle a moderate amount of pressure, and show attention to detail.

• Ability to work collaboratively with cross-functional groups with minimal supervision to ensure that the most optimal solutions are achieved in alignment with department strategies.

• Excellent interpersonal skills and professional attitude are essential as this individual interacts with many people of varying levels of responsibility for clinical studies and business performance.

• Excellent verbal and written communication skills.

• Ability to effectively collaborate in a dynamic environment.

• Direct experience with setting up IRT systems.

• Working knowledge of drug development process (Phase I-IV).

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• Degree in Life Sciences (e.g. Biology, Chemistry, Pharmaceutical) or business degree or equivalent.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Research Scientist I 

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Research Scientist I.

The Research Scientist I will support all aspects of biology activities related to multiple pre-clinical programs and represent research in clinical development programs. This will include individual ownership of certain programs and shared responsibility for others.

Essential duties and responsibilities include but are not limited to the following:

• Role will entail working closely with Medicinal chemistry to drive selected discovery research programs; this includes assay design for screening compounds, investigating mechanism of action and in vitro/in vivo pharmacology and evaluation and analysis of data.

• Participate in brainstorming and evaluation of ongoing programs and new project proposals.

• Develop cost effective and time efficient solutions for the execution and support of discovery research programs.

• Interface with colleagues in Medicinal Chemistry, DMPK, Toxicology and Biomarkers & Diagnostics to provide research support required to meet corporate goals.

• Interface with Intellectual Property to provide biology information required to support new and follow on patent filings.

• Interact with a chemistry team in India and a biology team in Chile. This may involve travel to India or Chile on an as-need basis.

Requirements:

• Experience in cell biology assays, including WB, protein purification and quantification and cell-based assays is essential.

• Experience in in vitro biochemical assays, including enzymatic assays.

• Experience in in vivo based pharmacology, including small molecule pharmacology and biologics.

• Experience performing animal behavioral studies is a plus.

• Strong scientific basis with experience independently driving a project and working as part of a team to push a project forward.

• Working knowledge of the process of drug discovery and development with working knowledge of the progression of compounds thru the discovery cycle into pre-clinical and clinical development.

• Strong organizational skills and ability to effectively manage multiple priorities, projects and logistics, must be able to multi task.

• Good written and verbal communication skills.

• Preference for ability to communicate in Spanish to support interface with a biology team in Santiago, Chile.

• Strong pharmacology background, an emphasis in immunology and neuroscience is preferred but not required.

• PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint); Adobe Acrobat.

Education:

• Ph.D. and Post-doctoral experience.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Clinical Trial Manager I

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Clinical Trial Manager I.

The successful candidate will have the skills necessary to thrive in a dynamic and growing company environment, as he/she assists Clinical Research staff in the conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials. Particularly important skills include flexibility; logical thinking; ability to prioritize day-to-day and critical tasks; willingness to adapt quickly to changing business conditions and learn new skills; interpersonal and team building skills. 

Essential duties and responsibilities include but are not limited to the following:

• Responsible for the implementation of clinical trial activities as defined by the Study Management Team. Works closely with investigative site personnel, CROs, and other study vendors under the direction of a Sr. CTM or CPM.

• May act as the lead for a region in a global trial.  Partner with and manage regional or global CROs on the conduct of the trial.

• Manages defined aspects of clinical trials at Medivation to ensure trials are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.

• Perform the activities associated with the implementation and monitoring of clinical trials such as development of study plans and materials.

• Assist with the projection and management of both clinical and non-clinical supplies.

• Works with Medical Monitor and study lead to select investigative sites, train investigators and investigative site staff, prepare materials for investigator meetings.

• Generates and maintains study timelines.  Identifies and communicates trial issues that will impact budget, resources and/or timelines.

• May participate in oversight monitoring activities, as needed.

• Previous on-site monitoring experience is required.

• Experience creating and/or reviewing monitoring reports and monitoring visit letters is required.

• Reviews and critiques electronic CRFs for accuracy and completeness. 

• Oversees data discrepancy management and training as needed.

• Provides or assists with training  internal and external CRAs, CRO team members, and investigative site staff.

• If managing a vendor, responsible for review of invoices for accuracy compared to work known to be performed by the vendor, under the guidance of senior Clinical Operations team members.

• Ensures that supportive study documents are completed (e.g., scopes of work, work orders, IXRS specification documents, specific IXRS scripts, non-clinical supply materials).

• May aid in the development of technical specifications for vendors (e.g. scope of work).

• Contributes to wider organizational goals and/or activities as assigned.

Requirements:

• 2-5 years industry experience in drug development, including prior site monitoring experience; Phase III Urology or Oncology experience preferred but not required.

• Knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials.

• Proficiency with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems.

• Must be self-motivating and be able to follow directions precisely, prioritize and manage a large volume of work, and show attention to detail.

• Strong interpersonal skills and professional attitude are essential as this individual interacts with many people of varying levels of responsibility for clinical studies and business performance.

• Excellent communication and interpersonal skills.

• Must be able to write clearly and summarize information effectively.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• BS or equivalent.

• Licenses or Certifications: Not required, but recommended.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Clinical Trial Manager I

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Clinical Trial Manager I.

The successful candidate will have the skills necessary to thrive in a dynamic and growing company environment, as he/she assists Clinical Research staff in the conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials. Particularly important skills include flexibility; logical thinking; ability to prioritize day-to-day and critical tasks; willingness to adapt quickly to changing business conditions and learn new skills; interpersonal and team building skills. 

Essential duties and responsibilities include but are not limited to the following:

• Responsible for the implementation of clinical trial activities as defined by the Study Management Team. Works closely with investigative site personnel, CROs, and other study vendors under the direction of a Sr. CTM or CPM.

• May act as the lead for a region in a global trial.  Partner with and manage regional or global CROs on the conduct of the trial.

• Manages defined aspects of clinical trials at Medivation to ensure trials are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.

• Perform the activities associated with the implementation and monitoring of clinical trials such as development of study plans and materials.

• Assist with the projection and management of both clinical and non-clinical supplies.

• Works with Medical Monitor and study lead to select investigative sites, train investigators and investigative site staff, prepare materials for investigator meetings.

• Generates and maintains study timelines.  Identifies and communicates trial issues that will impact budget, resources and/or timelines.

• May participate in oversight monitoring activities, as needed.

• Previous on-site monitoring experience is required.

• Experience creating and/or reviewing monitoring reports and monitoring visit letters is required.

• Reviews and critiques electronic CRFs for accuracy and completeness.  Oversees data discrepancy management and training as needed.

• Provides or assists with training  internal and external CRAs, CRO team members, and investigative site staff.

• If managing a vendor, responsible for review of invoices for accuracy compared to work known to be performed by the vendor, under the guidance of senior Clinical Operations team members.

• Ensures that supportive study documents are completed (e.g., scopes of work, work orders, IXRS specification documents, specific IXRS scripts, non-clinical supply materials).

• May aid in the development of technical specifications for vendors (e.g. scope of work).

• Contributes to wider organizational goals and/or activities as assigned.

Requirements:

• 2-5 years industry experience in drug development, including prior site monitoring experience; Phase III Urology or Oncology experience preferred but not required.

• Proficiency with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems.

• Must be self-motivating and be able to follow directions precisely, prioritize and manage a large volume of work, and show attention to detail.

• Strong interpersonal skills and professional attitude are essential as this individual interacts with many people of varying levels of responsibility for clinical studies and business performance.

• Excellent verbal and written communication skills.

• Ability to effectively collaborate in a dynamic environment.

• Phase III Oncology or Urology experience preferred but not required.

• Global trial and CRO management experience is preferred.

• Experience creating and/or reviewing monitoring reports and monitoring visit letters is required.

• Breast Cancer Experience is a plus.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

• Knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials.

Education:

• BS or equivalent.

• Licenses or Certifications: Not required, but recommended.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Senior Clinical Trial Manager 

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Clinical Trial Manager. The successful candidate will have the skills necessary to thrive in a dynamic and growing company environment, as he/she assists Clinical Research staff in the conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials. Particularly important skills include flexibility; logical thinking; ability to prioritize day-to-day and critical tasks; willingness to adapt quickly to changing business conditions and learn new skills; interpersonal and team building skills.   

Essential duties and responsibilities include but are not limited to the following:

• Provide managerial support to one or more employees (e.g., CSAs/CRAs/CTMs) with overall responsibility of leading, training, and mentoring for effective performance.

• May be responsible for independently managing the full scope of study conduct (start-up through database lock) and coordinating cross-functional efforts to achieve study objectives and goals.

• Assist/or drive managing defined aspects of clinical studies at Medivation to ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.

• Perform the activities associated with the implementation, management, and monitoring of clinical trials, including monitoring report and Informed Consent Form review.

• Assist in the preparation of clinical study reports, annual reports, IND updates, etc.

• Work with Medical Monitor and CPM to select investigative sites, train investigators and investigative site staff, prepare materials for investigator meetings, and manage clinical supplies.

• Identify and communicate study issues that will impact budget, resources and timelines.

• Review and critique CRF for accuracy and completeness.  Oversee data discrepancy management and assist with mapping as needed.

• Make recommendation on appropriate study vendor(s) to Director or CPM and independently manage vendor(s) to achieve project goals.

• Partner with business operations to ensure vendor agreements, change orders and site budgets meet clinical operations specifications.

• May be responsible for review of invoices for accuracy compared to work known to be performed by the vendor, may be done under the guidance of a senior clinical operations team member.

• Contribute to wider organizational goals.

• Other duties as assigned.

Requirements:

• 8+ years of industry experience in drug development, including prior site monitoring experience. 

• Previous line management experience or extensive mentorship experience. 

• Knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials.

• Proficiency with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems.

• Must be self-motivating and be able to follow directions precisely, prioritize and manage a large volume of work, and show attention to detail.

• Strong interpersonal skills and professional attitude are essential as this individual interacts with many people of varying levels of responsibility for clinical studies and business performance.

• Phase III Oncology or Urology experience preferred but not required.

• Global trial and CRO management experience is preferred.

• Site personnel (e.g., Principal Investigators, Study Coordinators).

• Manage study vendors, as needed.

• PC literacy required; Proficient use of technology including MSOffice skills (Outlook, Word, Excel, PowerPoint). 

Education:

• BS/BA in Life Science or related discipline.

• Licenses or Certifications: Clinical Research certification preferred, but not required.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Regulatory & Quality Systems Analyst (Contract)

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of Regulatory & Quality Systems Analyst (Contract). The position’s primary purpose is to support Regulatory and Quality Computerized Systems including implementation, validation, and system maintenance activities. 

Essential duties and responsibilities include but are not limited to the following: 

Day-to-day system administration of Regulatory and Quality Systems, including:

• User Training.

• Permissions management.

• Creation of reports as needed.

• Customer support.

• System administration / configuration of Regulatory and Quality Systems.

• Maintenance of detailed system documentation.

Collaborate with BPO and QA Validation on computerized systems validation activities:

• Author and/or execute installation and functional qualification tests.

• Update Regulatory and Quality computerized systems documentation.

• Author Change Control documentation.

Lead and/or support the implementation of new Regulatory and Quality computerized systems:

• Work with vendor to define hardware requirements.

• Collaborate with IT to define infrastructure and security requirements for new computerized systems.

• Perform software installations.

• Design and update system configuration to implement user requirements.

• Resolve technical issues as needed.

Requirements:

• Four years of experience working on validated systems in a regulated environment.

• Direct hands-on experience validating GxP Computer Systems.

• End user training and support.

• Generally IT Savvy and excellent problem solving skills.

• Demonstrated excellent customer service skills.

• Advanced user of Microsoft Word.

• Server, database and computer networking knowledge, including exposure to SQL.

• Exposure to Regulatory and/or Quality Computerized systems, including eCTD publishing systems and Quality management systems.

• Project management skills.

• Excellent analytical skills.

• Excellent verbal and written communication skills.

• Ability to effectively collaborate in a dynamic environment.

• Server, database and computer networking knowledge, including exposure to SQL.

• Exposure to Regulatory and/or Quality Computerized systems, including eCTD publishing systems and Quality management systems a plus.

• Experience managing GxP Computerized System implementation projects.

• Generally IT Savvy and excellent problem solving skills.

• Good oral and written communications skills.

• Able to work independently.

Education:

• Bachelor’s degree or equivalent work experience. 

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Manager, Commercial IT Systems

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of Manager, Commercial IT Systems. As a member of the Information Systems team, this individual will plan, design, configure, deploy and administer systems that support the Commercial and Medical Affairs organizations at Medivation. These include Customer Relationship Management, Promotional Materials Management, Scientific and Medical Materials Management and Closed Loop Marketing. The Manager, Commercial & Medical Affairs Systems must be able to provide both application support in an analyst capacity as well as technical support. This includes system evaluation and selection, project management, business analyst work and performing system administration functions. This individual will apply proven communication, analytical, and problem-solving skills to help maximize the benefits of IT investments.

Essential duties and responsibilities include but are not limited to the following: 

Strategy & Planning

• Identify and evaluate opportunities for IT to support Commercial & Medical Affairs business strategy.

• Provide options and recommendations to all levels of management.

• Build and maintain excellent relationships with business partners and IT team.

Acquisition & Implementation

• Lead projects from initiation through implementation.

• Collaborate in the planning, design, configuration, and deployment of new applications, and enhancements to existing applications.

• Facilitate user requirements definition and ensure applications meet these requirements.

• Partner with the Data Warehouse, Business Intelligence and Commercial Operations teams on systems integration and upgrade projects.

• Collaborate with team members, designers, vendors, and system owners in the testing of new features and applications.

• Ability to develop test plans, test protocols and lead execution of tests.

Operational Management

• Maintain (patch), repair and manage new and existing systems adhering to IT processes.

• Create and maintain technical and end-user documentation.

• Provide day-to-day and scheduled application support; respond to application support issues from multiple business customers.

• Manage and work with multiple vendors.

• Manage and provide system administration support of assigned applications.

• Partner with Date Warehouse, Business Intelligence and Commercial Operations teams to assist with data quality and processing activities and issues.

• Identify and resolve application issues.

• Act as department subject matter expert for system administration and operational support including user and security management, hierarchies, roles, data management, and report creation.

• Serve as system administrator for CRM and Materials Approval Application and be responsible for post-production end-user support.

• Other duties as assigned.

Requirements:

• Minimum of 3 years of experience with Commercial business processes and IT landscape in support of these processes.

• Minimum of 5 years of IT experience in planning, implementation and support of software solutions in a disciplined environment (e.g. ITIL).

• 4+ years of CRM administration and operational support, ideally with Veeva or the Salesforce platform.

• 3+ years direct experience managing enterprise applications and/or systems management with a focus on Commercial. 5+ years direct experience in IT.

• Proven track record of excellent project management.

• Knowledge of and experience with implementing IT solutions that facilitate regulatory compliance for Life Science Commercial business processes including aggregate spend, materials review and approval and data privacy practices and laws.

• Familiarity with customer and sales data and CLM.

• Business process/requirements analysis and re-engineering experience.

• Excellent listening and interpersonal skills.

• Strong customer-service orientation.

• Ability to communicate and work effectively with field-based and non-technical users.

• Good documentation skills and ability to design functional specifications, test scripts, and training documents.

• Strong verbal and written communications skills, able to present information and make recommendations to management and individuals.

• Ability to manage resources (contractors, managed services, etc) effectively including offshore personnel.

• Demonstrated strong analytical, critical thinking and problem solving skills in making appropriate decisions.

• Ability to conduct research into application issues and products.

• Highly self-motivated and directed and willing to take on new responsibilities and professional challenges.

• Keen attention to detail and highly organized.

• Ability to effectively prioritize and execute tasks in a high-pressure and evolving environment.

• Experience working in a team-oriented, collaborative environment. 

• Ability to effectively collaborate in a dynamic environment.

• Life Sciences industry experience preferred; 21 CFR Part 11 compliance; Extensive experience with core software applications, including CRM, CLM (including mobile platforms); Working knowledge of network and Windows PC operating systems.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• Four-year college diploma or university degree in MIS, computer systems design or computer science. 

• Licenses or Certifications: Certifications in project management and Veeva CRM preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Contracts Administration Assistant (Contract)

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Contracts Administration Assistant (Contract).  

Essential duties and responsibilities include but are not limited to the following:

• Review executed contracts to ensure contract fundamentals are completed appropriately and internal contract form is completed accurately.

• Ensure all contracts are entered into contract database, named and labeled according to the naming convention, and filed in electronic and paper files.

• Responsible for completeness, orderliness and accuracy of all contract files (electronic and paper) and for rapid retrieval of contracts as needed.

• Track the status of incomplete or inaccurate contracts or forms returned to contract requestor to ensure resubmission of documents for processing.

• Be the primary point of contact to resolve contract process questions and questions regarding the location or status of contracts.

• Run quarterly report for expiring agreements; review each agreement; find out if internal clients would like to extend the agreements.

• Examine electronic files and dispose of pages per the Medivation Record Management and Retention Program.

• Act as back-up for the contract request and approval system.

• Support internal and external audits.

• Other projects and duties as needed.

Requirements:

• 2 years of experience supporting contract administration/management.

• Strong organizational skills and meticulous attention to detail.

• Analytical and creative thinking with the ability to problem solve and use common sense.

• Proven performance in time management and multi-tasking.

• Self-motivated and able to work independently.

• Excellent interpersonal and customer service skills.

• Excellent verbal and written communication skills.

• Ability to build professional relationships and effectively collaborate in a dynamic environment.

• PC literacy required; MSOffice skills (Outlook, Word, Excel) 

Education:

• BA/BS required.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity 

Project Manager, Project Management   

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Project Manager, Project Management.  The Project Manager will work closely with cross-functional teams. Internally, s/he will interface directly with multiple functional areas such as: clinical development, clinical operations, toxicology, regulatory affairs, translational medicine, manufacturing, and other functional groups, as required by the projects s/he is assigned to manage. The objective of this role is to work closely with the Project Team Leader to ensure effective and efficient research, development and communication.

Essential duties and responsibilities include but are not limited to the following:

• Work with project teams to develop project plans that delineate team objectives, activities, timelines and resources required. 

• Focus and manage the project team to accomplish the stated objectives on time and on budget.

• Provide the project management skills to add value to each cross-functional project by ensuring excellent communication, clear direction of objectives, milestones and timelines.

• Manage highly-functioning teams in partnership with the Project Team Leader to proactively identify, manage and quickly resolve issues and problems.

• Collaborate closely with each functional area to ensure projects are optimally staffed and are moving effectively towards their milestones.

• Inform senior management of operational, budgetary or resource issues/obstacles in a timely fashion.

Requirements:

• 3-5 years experience in project management in the life science.

• Prior experience in project management within the Biotech/Pharmaceutical industry, required.  Must have had experience in managing projects that had a = 2-year timetable for completion involving tasks from a range of disciplines.

• Understanding of the pharmaceutical products culture and the special requirements of completing projects within a regulated environment.

• PMP certification a plus.

• Strong Leadership Skills.

• Strategic thinker – ability to stay one step ahead of the program by having both strategic and tactical views.

• Excellent interpersonal, organization, problem-solving, verbal and written communication skills.

• Attention to detail.

• Ability to organize and prioritize tasks in a timely and accurate manner.

• Ability to meet tight deadlines.

• Ability to work collaboratively in a dynamic environment.

• A solution seeker.  A person who is predisposed to find opportunities for improvement and can recommend solutions. 

• Effective interpersonal and communication skills. 

• Highly Proficient with the following computer systems: MS Project, MS Office (Word, Excel, PowerPoint), familiarity with SharePoint and Webex (or other similar systems).

Education:

• BS/BA degree required; advanced scientific degree preferred.

• Licenses or Certifications: PMP certification a plus.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Sr. QA Computer Systems Validation Analyst (Contract)   

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Sr. QA Computer Systems Validation Analyst (Contract).  The Sr. QA CSV Analyst will provide a QA oversight for the GxP computerized system validation activities within Medivation. This individual must be self-motivated, have excellent interpersonal and customer service skills and the ability to build professional relationships 

Essential duties and responsibilities include but are not limited to the following:

• Works with systems owners to ensure validation is conducted prior to deployment of GxP systems and systems are maintained in a validated state.

• Work closely with IT and business units to ensure Medivation is meeting relevant GxP regulations, such as 21 CFR Part 11 and Annex 11.

• Participate in system implementation project teams and provide guidance to ensure that validation documentation meets regulatory and Medivation's standards.

• Assist with the authoring and review of validation documentation.

• Participate in internal audits.

• Ensures adherence to quality standards during the development and implementation of GxP systems, identifies areas of strengths and weakness.

• Engage strong interdepartmental, cross-functional and organizational relationships to drive system requirements.

• Other duties as assigned.

Requirements:

• Minimum 7 years of experience in computerized systems validation (minimum of 4+ years in quality assurance role providing QA oversight of computerized GCP systems validation activities).

• Working knowledge of how to effectively perform software validation in a GxP regulated environment.

• Broad knowledge of SDLC methodologies.

• Should possess good business acumen and be able to relate applications to business needs.

• Excellent verbal and written communication skills.

• Ability to effectively collaborate in a dynamic environment.

• Self-motivated and good at multi-tasking.

• Proactive.

• Creative Thinker/Problem Solver.

• Working knowledge of how to effectively perform system validation in a GxP regulated environment (preferably GCP environments).

• Broad knowledge of SDLC methodologies.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• Bachelor’s degree in physical, life, or computer sciences or a related field.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Senior Scientist/Associate Director, Medicinal Chemistry  

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Scientist/Associate Director, Medicinal Chemistry.

Medivation is seeking a Computational Chemist who is well versed in Medicinal Chemistry or a Medicinal Chemist with experience in Computational Chemistry in The Associate Director of Medicinal Chemistry will support aspects of medicinal chemistry activities related to multiple pre-clinical programs and represent research in clinical development programs. This will include individual ownership of certain programs and shared responsibility for others. 

Essential duties and responsibilities include but are not limited to the following:

• In conjunction with the Chemistry team, drive selected medicinal chemistry activities to support research and development activities; this includes oversight, goal setting and prioritization of synthetic chemistry efforts of a chemistry team in India for at least 2 projects.  This will entail regular teleconferences with chemists in India as well as travel to India.

• Interface with Intellectual Property to provide chemistry and biology information required to support new and follow on filings .

• Interface with Project Management, CMC, Toxicology and Clinical to provide research support required to meet corporate goals of identifying clinical development compounds.

• Participate in brainstorming and evaluation of new proposals and ideas.

• Develop cost effective solutions for the execution of medicinal chemistry and first scale up activities to support discovery and early development programs.

Requirements:

• Working knowledge of the process of drug discovery and development and familiarity with the progression of compounds through the discovery cycle into pre-clinical and clinical development.

• Direct experience with management of CRO’s.

• Strong organizational skills and ability to effectively prioritize and manage multiple projects.

• Good written and verbal communication skills.

• Ability to travel domestically and internationally is essential.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint). 

Education:

• Ph.D. with 6-8 years of industry experience in small molecule drug discovery and development.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

CMC Senior Project Manager / Associate Director of Project Management  

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of CMC Senior Project Manager / Associate Director of Project Management. 

The Senior Project Manager / Associate Director of Project Management will work closely with the multi-disciplinary CMC teams to bring new product candidates through from target validation to IND filing (or ex-US equivalent) and move them into Clinic to fill Medivation’s pipeline.  Internally, s/he will interface directly with multiple functional areas such as: pharmacology, manufacturing, clinical development, regulatory affairs, quality, and clinical operations as required by the projects s/he is assigned to manage.  The objective of this role is to work closely with the Project Team Leader to ensure effective and efficient research and development of assigned project(s).

Essential duties and responsibilities include but are not limited to the following:

• Provide strategic project and process management support to cross-functional teams by ensuring excellent communication, clear direction of objectives, milestones and timelines with a focus on budget and resources. 

• Lead CMC Teams throughout the study planning, conduct, data management.

• Work with the project teams to develop integrated project plans (options development, risks management, opportunities identification, timing) that reflect the approved balance of scope, time, and resources.

• Manage highly-functioning teams in partnership with the CMC Team Leader to proactively identify, manage, and quickly resolve issues and problems.

• Implement tracking and reporting process to monitor product development status including analyses of timelines, resources and budgeting information that facilitate scenario planning, contingency planning, risk assessment, decision-making, and problem-solving.

• Manage clear and effective communication with key internal/external stakeholders to ensure initiative alignment, follow-through and execution.

• Develop and maintain strong, collaborative relationships with key stakeholders and organization.

• Collaborate closely with each functional area to ensure projects are optimally staffed and are moving effectively towards their milestones.

• Inform senior management of operational, budgetary or resource issues/obstacles in a timely fashion.

• Responsible for the execution of high quality project management to ensure the achievement of clinical development goals consistent with the product development objectives.

• Ensure high quality team performance by providing problem solving and decision making guidance to teams.

• Contribute to the implementation of new project management processes and policies to advance growth and development of the PM function.

Requirements:

• Experience: 5-7 (SPM) and 8-10 (AD) years of project management (preferably CMC) experience in the life sciences industry.

• Solid understanding of the drug development process with significant leadership experience.

• Excellent analytical skills (problem structuring and problem solving), able to handle complex analyses.

• Solid knowledge of overall drug development process relevant to pharmaceutical/biotech organizations.

• The candidate must have an understanding of the pharmaceutical/medical products culture and the special requirements of completing projects within a regulated environment. 

• Passionate, positive attitude with proven ability to motivate others to perform their best.

• PC literacy required: MS Office skills (Word, Excel, PowerPoint, MS project), Outlook or similar calendar system, SharePoint and Webex (or other similar systems).

• Excellent interpersonal and verbal and written communication skills with demonstrated ability to effectively drive to achievement of objectives.

• Proven ability to effectively collaborate in a dynamic environment.

• Experience leading successful strategic initiatives in a growing matrixed organization.

• PMP certification a plus.

Education:

• BS/BA; Advanced degrees in science, engineering, and/or business (e.g. PhD, MD, MBA) is preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Director of Project Management for XTANDI 

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Director of Project Management for XTANDI.

The Director/Global Regulatory lead will be responsible for developing and implementing robust global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders. 

Further, the incumbent will have regulatory accountability globally for assigned programs, working with other members of the regulatory team for ensuring timely completion and high quality regulatory deliverables.  This individual will provide leadership and strategic regulatory guidance to teams for designated projects ensuring that the latest requirements, standards and trends within the company and industry are met.  He/she will also provide line management, people development, and performance management as well as support development and implementation of department policies.

Essential duties and responsibilities include but are not limited to the following:

• Provide excellent strategic project and process management skills to cross-functional teams by ensuring excellent communication, clear direction of objectives, milestones and timelines with a focus on budget and resources. 

• Lead Medivation XTANDI Core Team and Joint Teams with Astellas throughout the study planning, conduct, data management and lifecycle management.

• Work with the project teams to develop integrated project plans (options development, risks management, opportunities identification, timing) that reflect the approved balance of scope, time, and resources.

• Manage highly-functioning teams in partnership with the Project Team Leader to proactively identify, manage, and quickly resolve issues and problems.

• Implement tracking and reporting process to monitor product development status including analyses of timelines, resources and budgeting information that facilitate scenario planning, contingency planning, risk assessment, decision-making, and problem-solving.

• Manage clear and effective communication with key internal/external stakeholders to ensure initiative alignment, follow-through and execution.

• Develop and maintain strong, collaborative relationships with key stakeholders and organization.

• Collaborate closely with each functional area to ensure projects are optimally staffed and are moving effectively towards their milestones.

• Inform senior management of operational, budgetary or resource issues/obstacles in a timely fashion.

• Responsible for the execution of high quality project management to ensure the achievement of clinical development goals consistent with the product development objectives.

• Ensure high quality team performance by providing problem solving and decision making guidance to teams.

• Contribute to the implementation of new project management processes and policies to advance growth and development of the PM function.

• Assist in and manage annual business planning and portfolio review including integration of information for Senior Leadership review and decision making regarding assets in the Product Portfolio.

• May be responsible for managing one or more highly complex and/or high profile project teams.

• Promote Medivation values and create a forward looking culture of ownership and accountability.

• Provide direct managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance.

• Other duties as assigned.

Requirements:

• 10+ years of experience in the life sciences industry with 3-5 years direct drug development project management.  Demonstrated experience managing drug development projects, while considering portfolio value drivers. 

• Extensive understanding of the drug development process with significant prior management and leadership experience.  Solid knowledge of working within a regulated industry.

• Demonstrated project leadership skills in delegating, influencing and in managing budgets, resources, and priorities.

• Excellent analytical skills (problem structuring and problem solving), able to handle complex analyses.

• Extensive knowledge of overall drug development process relevant to pharmaceutical/biotech organizations.

• The candidate must have an understanding of the pharmaceutical/medical products culture and the special requirements of completing projects within a regulated environment. 

• Passionate, positive attitude with proven ability to motivate others to perform their best.

• PC literacy required: MS Office skills (Word, Excel, PowerPoint, MS project), Outlook or similar calendar system, SharePoint and Webex (or other similar systems).

•  Excellent interpersonal and verbal and written communication skills with demonstrated ability to effectively drive to achievement of objectives

• Proven ability to effectively collaborate in a dynamic environment.

• Experience leading successful strategic initiatives in a growing matrixed organization.

• PMP certification a plus.

Education:

• Advanced degrees in science, engineering, and/or business (e.g. PhD, MD, MBA) or commensurate experience.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Senior Director, Regulatory Affairs CMC

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Director, Regulatory Affairs CMC.

The Senior Director, Regulatory Affairs CMC will be responsible for developing, implementing, and advising on global CMC regulatory strategies for new and late stage programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders.  This individual will provide leadership, high level strategic and operational regulatory direction and mentorship on projects including, but not limited to CMC regulatory strategies, CMC regulatory requirements for clinical studies and marketing approval in domestic and international markets, CMC regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions while ensuring that the latest requirements, standards and trends within the company and industry are met.  The individual has departmental and corporate level influence and acts as an advisor/liaison to senior management in order to plan, evaluate and recommend CMC regulatory strategy.  Externally, the individual will interface with outside regulatory agencies and business partners in regards to CMC development, regulatory, and registration strategies.  He/she will also provide line management, people development, and performance management as well as support/lead development and implementation of department policies. The individual will also maintain awareness of global regulatory environment and assess and communicate impact of changes on business and product development programs.  Further, this individual will proactively facilitate any changes needed to internal policy or on development/regulatory strategies.

Essential duties and responsibilities include but are not limited to the following:

• Provides high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general CMC regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions.

• Uses extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.

• Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources.

• Able to articulate complex Regulatory CMC issues; Facilitate the development and submission of technically complex CMC submissions to support global development and commercialization of early and late state programs.

• Oversees the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met.

• Reviews CMC sections of IND/CTA, NDA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.

• Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key CMC regulatory issues and to expedite approvals of product.

• Maintains awareness of global regulatory environment and assess impact of changes on business and product development programs.  Facilitate policy and development of standard interpretation of global regulation.

• Proactively influences internal and external CMC regulatory policies and guidances.

• Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business.

• Trains, develops, and manages an effective regulatory team both via direct and indirect reporting structure (Clinical, RA Operations, Labeling and Promotion).

• Leads special regulatory projects/process initiatives of high complexity.

• Proactively manages critical CMC issues, taking leadership for the regulatory contribution.

• Supports executive team on due diligence, CMC regulatory intelligence, and regulatory affairs initiatives.

• Serves on senior staff committee responsible for developing and implementing department policies.

• Identifies continuous improvement opportunities and takes action to improve processes and metrics for current performance and for scaling the business.

• Recruits, develops, manages and mentors regulatory professionals and drives a culture of excellence and motivates employees to perform at their highest ability. Rewards and recognizes employees and teams who take initiative beyond expectations to advance business goals. 

Requirements:

• A minimum of 10 years in the biotechnology or pharmaceutical industry and a minimum of 10 years in a Regulatory capacity with a broad background.  Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas and prior experience with both small molecules and biologics.

• Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and market and policy trends .

• Extensive regulatory experience across value chain including IND/CTA, NDA/BLA/MAA, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing complex CMC regulatory strategies with a proven track record of significant regulatory accomplishments.

• Proven ability to motivate and lead people in a complex, changing environment, and the professional maturity to overcome ambiguity and lead others through both, influence and direct authority.

• Strong business acumen and ability to make sound decisions that contribute positively to the business.

• Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.

• Demonstrated leadership excellence and skills in delegating, influencing and in managing budgets, resources, and priorities. 

• Excellent verbal and written skills; Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders.

• Skilled in conflict resolution/negotiation.  Fosters open communication. Listens and facilitates discussion.

• Strong negotiating skills and ability to think creatively and develop creative solutions.

• Proven ability to build trust and respect within the organization.

• Ability to prioritize and handle multiple projects simultaneously.

• PC literacy required; Proficient use of technology including MSOffice skills (Outlook, Word, Excel, PowerPoint, document management systems, and Internet resources is expected).

• Business travel to be ~10-20% as required.

Education:

• Bachelor’s degree required, advanced degree preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

IT Manager / Senior IT Manager, R&D 

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of IT Manager / Senior IT Manager, R&D.

As a member of the Enterprise Applications team, the IT Manager / Senior IT Manager, R&D position will plan, design, configure, and deploy IT systems that support the Research and Early Development teams at Medivation. This position partners with management and scientists to shape the demand for and help to determine how best to support these areas through the effective use of data and technology. This individual leads cross-functional IT projects with focus on scientific data management to enable better and faster scientific decision-making in research projects. You will contribute to the IT architecture that supports R&D at Medivation and help define integration requirements across systems to facilitate progress of research projects through discovery and development pipeline. You will participate in IT planning activities and contribute to the strategic direction of the informatics area of focus for the team. And you will participate in analyzing data for Medivation nonclinical toxicology studies. 

Essential duties and responsibilities include but are not limited to the following:

• With thorough understanding of research processes and data flow, establishes and maintains the technical and scientific partnership with multiple scientific functions.

• Collaborates with IT teams to ensure delivery of IT services to the research teams in a high quality and timely manner.

• Leads highly visible, complex projects, programs or solutions that are critical to the research teams.

• Contributes to the strategic planning process and long-term direction for IT in support of Research and aligns plans between stakeholders.

• Contributes to the requirements for IT architecture that will best facilitate R&D at Medivation.

• Contributes to budget development and monitors budgets within projects.

• Manages and works with multiple external vendors of IT and informatics solutions and services.

• Performs all activities in compliance with relevant requirements/standards and controls.

• Performs data analysis for nonclinical toxicology studies in a timely manner. 

• Other duties as assigned.

Requirements:

• A minimum of 3 years of increasingly complex organizational responsibilities is required.

• A minimum of 5 years of working experience with database/application development and/or business analysis is required.

• Pharmaceutical research industry experience is required. In-depth understanding of research processes and scientific information is required.

• Knowledge of scientific data management approaches and research applications development cycles are required.

• Knowledge of infrastructure requirements is preferred.

• Proven leadership and industrial experience in driving projects under tight timelines is required.

• Excellence in project leadership and resource management with strong track record of project delivery is required.

• Proven stakeholder relationship management skills are required, preferably in a complex organization. Knowledge of SDLC and GxP/regulatory requirements is required.

• Candidate must be a self-starter with excellent people, leadership, analytical, and written/verbal communication skills.

• This role requires a hybrid of science, informatics/information technology and business analysis/engagement expertise.

• Experience with use, support, development and implementation of databases/ IT tools in support of biological sciences.

• Knowledge of data analysis/visualization tools (e.g., Graphpad Prism, Spotfire, MindMap etc.) and scripting tools (e.g., Knime, Pipeline Pilot).

• Maintains an excellent knowledge of evolving informatics tools and techniques.

• Excellent project management skills.

• Business and Technical Analysis skills and experience.

• Must have demonstrated background in FDA, EMA and other International GxP standards.

• Excellent verbal and written communication skills.

• Ability to effectively collaborate in a dynamic environment

• Excellent communication skills and strong drive to interact with researchers carrying out cutting-edge research.

• Great interpersonal skills, able to influence and engender collaboration.

• Attention to detail and excellent analytic skills.

• Well organized and able to work on own initiative.

• Flexibility with learning the scientific aspects of Medivation programs.

• Multidisciplinary team of scientists, clinicians and technology experts.

• PC literacy required; Proficient use of technology including MSOffice skills (Outlook, Word, Excel, PowerPoint). 

Education:

• A Bachelor’s degree with a minimum of 10 years of related work experience OR an advanced degree with a minimum of 5 years of related work experience is required.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity

Infrastructure Engineer / Senior Infrastructure Engineer

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of Infrastructure Engineer / Senior Infrastructure Engineer.

The Infrastructure Engineer will be responsible for the design, testing, and successful transition of Medivation’s internal and vendor-enabled infrastructure, massaging, storage, network, security & continuity services. You will work closely with the engineering team to define forward architectural road maps for Workplace and Infrastructure services and lead activities to resolve hardware and software problems in a timely fashion.

Essential duties and responsibilities include but are not limited to the following:

Acquisition & Deployment

• Design the architecture and deployment and development of IT services and associated processes and procedures.

• Work with Service Desk and Operations teams and vendors to facilitate deployment, monitoring, maintenance, development, upgrade, and support of IT services and associated processes and procedures.

• Conduct feasibility studies for various upgrade projects, improvements, and other conversions.

• Negotiate with vendors, outsourced, and contractors to secure infrastructure-specific products and services.

• Proactively support the planning and deployment of business and security projects to keep infrastructure work off the critical path.

• Develop disaster recovery plans, operational training and testing criteria to meet RTOs and RPOs for IT services. 

• Define hardware and software standards in conjunction with owners and stakeholders.

Operational Management

• Provide guidance, documentation and training to Service Desk and operations teams to facilitate ongoing management of all new or changed processes and technologies.

• Manage operational costs; conduct near- and long-term financial forecasts for expanded functionality/user base.

• Establish and maintain regular written and in-person communications with the organization’s executives, decision-makers, stakeholders, department heads, and end users regarding current infrastructure services, SLAs and future IT needs.

• Practice Change, Problem and Service Asset & Configuration Management best practices including maintenance of component inventory and related documentation.

Requirements:

• 7-10  years technical experience in designing complex multi-protocol networking environment with solid understanding of infrastructure architecture, network security best practices, and technical proficiency with the following emphasis:

• Cisco Unified Communication (CallManager, Unity, Cisco UC Integration for Microsoft Office Communicator, Nice call recording).

• Cisco  Switches, Routers, ASA Firewalls, Intrusion Detection, and WAN accelerators.

• Network Protocols (TCP/IP, EIGRP, OSPF, BGP, CIFS, iSCS, NFS and Multicast).

• Load-Balancers (F5 Local Traffic Manager and Global Traffic Manager).

• Network Management (Wireshark, Sniffer, TACACS, Cisco ACS, Kiwi Syslog, Cacti,  ManageEngine DeviceExpert and NetflowAnalyzer).

• Network Security ( RSA Authentication Manager / 2 Factor authentication, Palo Alto Firewall and IDS/IPS).

• Linux shell scripting including sed/awk and fluent on at least one high-level scripting language.

• Strong experience with Linux (Redhat, CentOS, Ubuntu).

• Experience working with a parallelized file system such as Isilon or Lustre and InfiniBand.

• Operations Services.

• Strong VMware vSphere  experience desired.

• Excellent verbal and written communication skills.

• Ability to effectively collaborate in a dynamic team-centric environment.

• Exceptional Customer Services skills required.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• Four-year university degree or college diploma in the field of computer science and/or 7-10 years equivalent work experience.

• Licenses or Certifications: ITIL Foundation, CCNP, CCISP, MSCE, MCP, VCP, CCIE, or other networking certifications preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity, M/F/D/V

Director, Operations

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of Director, Operations.

The Director, Medical Affairs (MA) Operations is responsible for the successful execution of the operational aspects of the Investigator Sponsored Research (ISR) program and assisting with coordination and/or tracking of Medical Affairs projects and initiatives through partnership with Medical Science Liaisons, Scientific Communications, Health Economics and Outcomes Research (HEOR), Preclinical, Clinical Development, Legal, Regulatory Affairs, Business Operations, Pharmaceutical Operations, and others as appropriate.  Additionally, forging productive and compliant partnerships with any Alliance partner is essential.  The candidate will report to the Senior Director, Medical Affairs who, in turn, reports to the Vice President, Medical Affairs.

Essential duties and responsibilities include but are not limited to the following:

• Leadership in the compliant execution of the global ISR program, including that of investigator sponsored trials (ISTs) and cooperative group trials

• • Manages the intake and review process for ISR concepts, protocols and amendments.

  • Generates and distributes appropriate, timely communications between the ISR Review Committee and investigators/site staff.

  • Initiates study start-up activities in collaboration with Medical Affairs, Legal, Regulatory Affairs, Business Operations, Pharmaceutical Operations, and others as appropriate.

  • Tracks and monitors patient enrollment, milestone payments, drug supply and other study-related activities throughout the life cycle of the ISTs.

  • Tracks study closeout activities.

  • Develops project plans and manages multiple projects to achieve goals within established timelines.

• Manages ISR budget.

• Designs and manages processes to ensure effective and efficient operational support, including leadership in MA Operations process improvement initiatives

• Represents MA Operations on assigned teams.

• Provides support for internal Medical Affairs audits.

• Provides general support, as requested, for Medical Affairs departmental projects.

• • Develop and deliver information in a clear and concise manner.

  • Develops effective working relationships with internal trial team .

  • Understands disease states and their treatment options and maintains knowledge of specific products.

• Provide support for Medical Science Liaison activities.

• Partner within the Organization to optimize cross-functional communication.

• Support effective coordination of partnership and internal Governance bodies.

• Support high-quality execution of Corporate-wide initiatives.

• Develop, track, execute and report on goals and objectives.

• Be accountable for compliant business practices.

• Provide managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance.

• Other duties as assigned.

Requirements:

• Minimum 7 years of clinical research experience in the biotech/pharmaceutical industry.

• Minimum of 5 years industry Operations experience, preferably in oncology.

• Global trial experience is preferred.

• Knowledge of the IST and cooperative group trial processes regarding the tracking and management of clinical studies.

• Understanding of the designated program strategy.

• Strategic and creative thinking.

• Strong problem solving and risk mitigation skills.

• Strong time management and organizational skills.

• Ability to manage multiple projects in a fast paced environment.

• Ability to build working relations throughout the organization and with business partners to achieve business goals.

• Appreciation of diversity and multiculturalism.

• Familiarity and understanding of Legal and Regulatory concepts and verbiage is required.

• Working knowledge of applicable Federal and State Compliance guidelines and regulations is required.

• Experience with partnerships and strategic alliances is preferred.

• Prior experience with vendor selection and management is desired.

• Working knowledge of applicable ex-U.S., Federal and State Compliance guidelines and regulations is required.

• Prior training and experience with Good Clinical Practice (GCP).

• Executive presence.

• Confident, positive attitude, enthusiastic and charismatic.

• Excellent and impactful verbal and written communication skills.

• Values based collaborator – respectful, accountable and collaborative.

• Ability to effectively collaborate in a dynamic cross-functional environment.

• Significant internal interactions, primarily among the different functional teams within Medical Affairs (including Medical Science Liaisons and Scientific Communications), Preclinical, Clinical Development, Legal, Regulatory Affairs, Business Operations, Pharmaceutical Operations.

• Significant external interactions, primarily with an Alliance partner, and experts within the prostate cancer community.

• Experience in clinical trial design, evaluation and execution.

• Knowledge and experience in clinical trial conduct, and its Legal and Regulatory requirements.

• Knowledge and understanding of Medical Affairs roles and function.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• Medical, science, or business degree.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity, M/F/D/V

GPO (Group Purchasing Organization) Account Manager

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of GPO (Group Purchasing Organization) Account Manager.

The GPO Account Manager will be responsible for fulfilling Medivation’s commitment to access for patients to our products. This individual will develop strategies and tactics for effective pull through efforts to ensure that the brand is supported in finding innovative and compliant ways to support Xtandi Growth in Oncology and Urology. The role will interface with several stakeholders including but, not limited to field sales, marketing and co-promote partners. By working with key customers in the field, this position will be a significant contributor to ensure that field sales’ needs are met and customers are knowledgeable of marketing programs in the GPO channel. In addition, this individual will have the opportunity to interface with Key GPO customers and work with them to create access for Xtandi. The position will report directly to the Director of Account Management. 

Essential duties and responsibilities include but are not limited to the following:

• Collaborate with sales team to pull-through approved field marketing programs (In-practice programs, speaker programs, etc.).

• Effectively communicate contract terms and MAP approved promotional materials, programs, and messages.

• Provide appropriate market access support to dispensing clinics per MDVN compliance guidelines.

• Identify market trends and be able to suggest solutions to the appropriate stakeholders.

• Identify, coordinate, and attend GPO conferences regionally and nationally.

• Coordinate and streamline field communications and logistics with co-promote account team.

• Collaborate on GPO meetings, contract development, and targeting with co-promote team to ensure alignment on corporate objectives.

Requirements:

• Minimum of 5 years proven track record in working with various Oncology GPO accounts and negotiating GPO contracting.

• Strong relationships with GPO accounts and key accounts leadership.

• Background in Oncology Sales or Marketing is a must. 

• Successful track record working in partnerships and strategic alliances is also preferred.

• Ability to meet job demands while maintaining a significant travel schedule.

• Demonstrated ability to work in a fast pace environment and manage multiple responsibilities and priorities.

• Must possess strong interpersonal skills and have the ability to influence without authority.

• Demonstrate the ability to manage complex relationships, have the balance of being able to work in a team and independently.

• Demonstrated ability to cultivate and manage challenging relationships as well as proven skills in crisis management, issues preparedness, and effective negotiating.

• Understand the pharmaceutical/ biotech business model, regulatory process and communications guidelines.

• Excellent verbal and written communication skills.

• Ability to effectively collaborate in a dynamic environment.

• Able to influence in a proactive, objective and diplomatic manner.

• Effective presentation and platform skills.

• Internal stakeholders including sales, marketing, market access and commercial leadership, legal, regulatory, executive management, and co-promote partners.

• External stakeholders including GPO organizations, large dispensing clinics and key opinion leaders.

• Strong Excel and PowerPoint skills would be desirable.

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).

Education:

• Bachelor’s degree is required.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity, M/F/D/V

Director, HRIS Operations and Analytics

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of Director, HRIS Operations and Analytics.

This role will be responsible for the Implementation, maintenance and maximization of HR Systems and analytics across the organization in support of the business.  The Director, HRIS Operations and Analytics will lead the selection, implementation and maintenance (including system upgrades) toward the goal of maximizing all HR Systems at Medivation. The role will also develop, and generate HR analytics and reports as well as assist in day-to-day reporting and ad hoc data analysis.

This role will work in conjunction with Compensation in the annual focal review (merit, bonus, and equity)  Working in a fast-paced environment, this individual will wear many hats and have a broad scope of responsibilities.  Flexibility and a service orientation are key success factors.

Essential duties and responsibilities include but are not limited to the following:

• Implement maintain and maximize Workday HRIS system.

• In conjunction with the Project Team, select and implement systems to automate and streamline day to day and seasonal HR tasks.

• Provide scheduled analytics and analysis by building and generating reports.

• Perform custom analysis and reporting to support HR and the Business Partners toward the goals in continuous improvement of HR quality.

• Responsible for generating HR metrics, while providing insight and analysis on trends to drive more informed HR/business decisions.

• Responsible for reporting and analysis from various systems including ADP Payroll.

• HR Lead for document retention and retrieval including SOX compliance requirements.

• This role is a key contributor in various HR projects and functions including working on teams and collaboration with individuals across functions.

• Leads and tracks (in conjunction with reports generated in Accounting) the Annual HR Budgeting and long range planning/tracking.