Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publically traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced individual for the position of Manager, Commercial Analytics.  (This position will be based out of our Chicago Office.)

The Manager, Commercial Analytics develops and delivers business insights to the commercial team through integration of secondary data sources, primary research, and custom analyses, and utilizes historical metrics to provide direction and forecasting to senior management.

Essential duties & responsibilities but not limited to the following:

• Provides accurate and in-depth analysis to cross functional leadership teams and serves as an integral part of the extended commercial team.

• Manages direct relationship with third-party data providers to support a cross-functional data governance team in the establishment and maintenance of data sources.

• Collaborates with the Marketing team to fulfill data analysis needs in support of key strategic initiatives which balance personal and non-personal promotion.

• Supports initiatives to segment and track physician behavior focused on driving optimal promotional efforts leveraging expertise in manipulation of large data sets using relational software, such as Access, SAS and/or SQL.

• Models physician, account, payer, and patient claims activity, and liaison with Astellas, as well as  external consultant support to access SPP /SD data to perform data analytics.

• Works closely with Health Systems to develop data metrics from reimbursement hub enrollments, benefit verifications and co-pay card tracking.

• Supports development of long-range forecast and scenario planning models which include scenarios of competitive market place changes, and new indications and formulations. 

• In collaboration with Marketing and Finance, develop simulation models for revenue forecasts and planning.

• Provide analytic support to Sales leadership in the IC plan design and forecast process.

• Analyzes impact of promotional programs, performs ROI, and guides optimization of promotional resource allocation.

• Designs and maintains business projection models by various market channels, and forecasts opportunities with revised business strategies.

Requirements:

• 5 Years in commercial analytics/forecasting/market sciences

• Strong IT, data management skills with requisite software systems, statistics, and forecasting

• Strong Interpersonal communication, both verbal and written

• Skilled at presentations to Senior Management

• Ability to have 50,000 feet view while also being able to “be in the weeds” with data.

Education:

• Bachelors degree (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, M/F/D/V

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, Commercial Operations, reporting directly to the  Director, Sales Operations & Systems/Compliance.

The primary purpose of the Senior Manager, Commercial Operations role is to support the Commercial organization in making effective business decisions, evaluating the performance and compliance of various field teams as well as managing a variety of internal operational processes to ensure an integrated and highly efficient Commercial function.  This mission will be accomplished through effective partnering and collaboration with other Commercial groups and functions including IT, Training, Marketing, Managed Markets, Compliance and others.  The scope of the role includes all of Commercial as well as Medical Affairs and Clinical Development and spans Sales Ops, Compliance, Marketing Sciences and Data Management functions.

Duties & Responsibilities but not limited to the following:

• Contribute his/her skills, knowledge, experience & abilities in helping to identify/create innovative strategies, plans & tactics that will help improve operational support and execution across multiple areas and in collaboration with key partners

• Provide clear, actionable and insightful analysis that positions the commercial team to implement and execute strategies aligned with market conditions

Sales Analytics’ Requirements & Reporting

• Acts as a subject matter expert for content and usage of internal sales data and databases

• Works with team and others to analyze current data sources and reporting mechanisms – conducting gap analysis – to determine specific updates/changes/new requirements to fulfill business partner needs, goals and objectives (includes understanding the data that exists internally & externally, assessing the data’s usefulness, determining what additional data to bring in-house)

• Develops the plans, projects, other activities, and goals for Sales Analytics by working with manager, peers, team members and reviewing with internal partners/stakeholders to ensure alignment to business partner requirements

• Collaborates with IT to ensure appropriate process, access and tools or all commercial data

• Works with Data Management and IT on development and reporting needs

• Reviews all data quality, integration and implementation requirements and other sales analytics’ specifications (to include specifications for data analysis) with relevant internal/external partners/stakeholders

Ongoing Analyses & Other Operations

• Works with internal partners/stakeholders and team members to identify ad hoc analyses and/or reports.

• Completes reporting and other administration as and when needed, assigned or requested

Incentive Compensation

• Acts as the subject matter expert and internal consultant on all  matters relating to sales incentive compensation 

• Conducts various research and/or benchmarking, as well as analyses and modeling in order to proactively recommend appropriate and best practice incentive compensation plan design and related plan management and administration approaches and activities

Requirements:

• Average of 6 or more years’ work experience with a minimum of 4 years’ specific, previous experience developing/managing business analytics in the pharmaceutical, biotech, or other related industry (includes previous, related consulting experience)

• Must demonstrate outstanding knowledge of business analytics and associated practices relevant to the pharmaceutical/biotech industries, e.g. experience with secondary market research data such as syndicated sales & marketing data, claims’ data, and longitudinal patient data; understanding of statistics and modeling techniques; experience with specific statistical analysis software; deep understanding of pharma data; Aggregate spend and or compliance experience desireable

• Proven track record for consistently meeting or exceeding qualitative, as well as any relevant quantitative, targets and goals

• Business travel, by air or car, is required for regular internal and external business meetings

Education:

• Bachelors Degree is preferred (general business, economics, mathematics, statistics, or industry-specific, such as health sciences, disciplines are a plus)

• MBA or other related graduate-level degree is a plus

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

The Commercial Data Manager/Senior manages the business Data Management function at Medivation.  They are responsible for partnering with their IT counterpart to set the vision and strategy for data, data related processes, syetems and functions.  As the owner of this function, you will be responsible implementing and maintaining data governance and stewardship to effect high quality and timely data availability throughout the commercial organization.  Additionally, this role will be responsible for managing a data catalog and ensuring visibility to, availability of, and responsible usage of our data assets.  Vendor management and balancing a portfolio of data products are also a key component of this role.

Duties & Responsibilities but not limited to the following:

Operations/Reporting

• Jointly responsible with IT counterpart for the vision, strategy, deliverables and resources within a Data Management functional area.  Primary escalation point for business community and IT

• Financial responsibility for deliverables, resources and business processes within a functional area

• Partnership with IT in implementing systems to support Medivation Sales and Marketing’s business processes as well as legal and compliance initiatives.  Implementation within an agreed upon timeline and budget.  Ultimate Business Owner for responsible systems

• Lead or participate in cross -functional data initiatives with customer and peer groups (Sale Ops, IT, Marketing, Sales, Legal)

• Provides day-to-day operational support for senior Commercial Ops staff in the following areas:

• Responsible for production and ad-hoc deliverables

• Ensure SLAs are met with each customer group

• Partner with IT ito ensure production SLA’s met

• Benchmark existing data model and business processes with industry standards.  Constantly exploring improvements to the existing data model and technology used to support our business processes.

Responsible for the staffing of resources needed to support a content area.  This might include FTE or Consultant/Temporary employees

• Manage and facilitate the candidate selection and hiring process with Medivation HR and Vendor for Contracting and Temporary staff

• Lead, manage and train both FTE and Consultant/Temporary employees to meet group objectives

• Ensure FTE employees (as necessary) have clear goals and objectives along with yearly development plans.  Facilitate the review performance review process

• Jointly define with IT counterpart, current and future business requirements in area of expertise for system production and development teams to implement

• Business Owner of workflow system/project regarding system enhancements for area of responsibility

• Collaborate with IT to prioritize workload for production resources in order to meet SLAs, manage customer expectations and resolve competing initiatives

• Create and monitor metric reports

• • Data Volume

  • Data Trends

  • SLA adherence

  • QC reports per system

  • Delta reports across systems

Vendor Management – (i.e. IMS, APUS, SHA, etc.)

• Establish vendor evaluation criteria to ensure best product and price combination is achieved

• Responsible for budget allocation of vendor product or services

• Completion of the Statement of Work by vendor

• Established deliverable and timelines

• Ensure quality of the product or service being purchased

• Coordinate on-going training and client site visits

• Ensure non duplicative acquisitions

• Periodically evaluate usage of and return on data investments

Requirements:

• 5 + years biotech / pharmaceutical experience in Sales Ops and/or Data Management 3+ years of data analysis and project management experience in Data Management

• In-depth experience with Pharmaceutical data such as IMS/Symphony retail and non-retail data

• Supervisory or management experience desirable

• Ability to assemble a wide variety of data, translate it into information, and communicate a summary of the information

• Strong communication skills, strong analytical and problem solving skills, and intermediate computer skills.  Computer skills should include but not be limited to Excel, Word, and Power point.  Ability to resolve complex issues with the sales force.  Ability to work effectively within a fast paced team environment is essential.

• Specific product knowledge in the pharmaceutical or biotechnology industry is a plus

Education:

• Bachelors degree

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publically traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Compliance Counsel reporting directly to the General Counsel and Chief Compliance Officer.

The Senior Compliance Counsel will manage and execute Medivation’s compliance programs, policies and procedures, in coordination with the Medivation Chief Compliance Officer and  legal department.  As well as inform, educate, and train Medivation colleagues on implementation of processes and procedures required by Medivation compliance programs and internal policies.

Essential Duties & Responsibilities but not limited to the following:

• Draft and execute Medivation compliance policies, procedures, and programs, including required by the Pharma Code and related to Medivation’s state and federal HCP expense tracking and disclosure obligations. 

• Provide oversight for Medivation compliance policies, procedures, and programs, which includes (1) risk identification, assessment and mitigation; (2) development of training curriculum and program in key areas; (3) updating of policies and procedures.

• Direct, manage and document compliance of Medivation colleagues with internal compliance policies, procedures, and programs.

• Coordinate communications, including update Medivation management environment and government investigations.

• Direct and assist compliance monitoring and auditing procedures, including vendor management.

• Manage and understand Medivation’s docket of compliance investigations, and assist with remediation and corrective actions for Medivation.

• Assist with preparing presentations and agenda for quarterly Compliance Committee meetings and deep dive Compliance topic meetings, in coordination with Chief Compliance Officer, and ensure execution of action items.

• Work closely with Medivation legal department to ensure consistency with compliance and legal advice and leverage best practices.

• Coordinate with Medivation business colleagues, legal and training to manage accurate records of Medivation training and compliance communications by business, and prepare timeline reports for Medivation compliance activities.

• Assist with field rides, compliance advisory boards, and attend field based activities (i.e., congresses and speaker programs) to monitor as needed.

Requirements: 

• Proven capabilities with 7 years overall legal experience including 5+ years of experience in some or all of the following areas:  healthcare law and policy, regulatory law, healthcare compliance, managed markets, antitrust, litigation or other commercial legal or transactions practice, and intellectual property

• Detail-oriented and strong organizational skills

• Strong business sense and understanding of the evolving business model

• Demonstrated strength in leadership, judgment and initiative

• Proven capabilities to set priorities, drive results, and act efficiently and effectively within a complex business and organizational environment

• Negotiating skills and transaction experience

• Analytical and creative thinking ability

Education: 

• JD and Admission to practice law in the US

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publically traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Statistical Programmer, reporting to the Associate Director/Head of Biometrics. 

The Senior Statistical Programmer will work in Medivation’s Statistical Programming group.  This position will be in a clinical programming area supporting primarily the Data Management group.  The position will report to the Head of Statistical Programming.


Essential duties & responsibilities but not limited to:

• Follow specifications and requirements to create Data Management listings and reports for database cleaning and maintenance.

• Communicate with Data Managers on data issues.

• Work with data managers and medical monitors to develop reporting specs.

• Work with Safety group to develop and generate reports for safety reconciliation.

• Communicate and work with offshore and remote team to address deliverables.

• Create tracking reports in excel and html formats for review by DM and Clinical study teams.

• Follow SAP and analysis specifications to create analysis datasets and TLGs.

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

• Create new macros and utilities for developing ensure programming efficiency.

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

Requirements:

• 6+ years clinical research and development programming experience

• Experience and knowledge of EDC systems such as Rave or Inform

• Experience in Clinical Trials data collection and review

• Experience in FDA/EMEA trial submissions
  Drug Development (pre-, early, late and/or observational) in related industries or academic research

• Computer programming using SAS

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

• Fundamentals of project planning and management

• Drug development process

Education:

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

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publically traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Manager Statistical Programming, reporting to the Associate Director/Head of Biometrics.

he Manager of Statistical Programming will work in Medivation’s Statistical Programming group in the Oncology Therapeutic area.  Position title and role will be commensurate with experience.  This position will report to Head of Statistical Programming within the Biometrics group.

Responsibilities:

• 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.

• Manage other programmers and lead programming for specific project(s).

• 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

• Write CDSIC standard dataset specifications and follow specifications to create SDTM and ADAM datasets.

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

• Provide input to and participate in intra-departmental meetings

• Contribute to the continuous improvement of Statistical programming group.

• Assist in the 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.

• Attend external professional organizations, conferences, training and/or meetings
  

Requirements

• 10+ years clinical research and development programming experience

• Computer programming using SAS

• Understanding of computer operating systems, word processors, document applications
  Fundamentals of project planning and management

• Drug development process

• Extensive hands-on experience in CDSIC standards and datasets (SDTM, ADAM)

• Experience in Oncology Trials

• Experience in FDA/EMEA trial submissions
  Drug Development (pre-, early, late and/or observational) in related industries or academic research

Education:

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

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, Biostatistics, reporting directly to the Senior Director, Biostatistics.

This position oversees statistical aspects of assigned projects and provides support in study design, statistical analysis, and reporting of data. Plans, organizes, coordinates, and reviews activities of biostatistics activities for assigned projects. Coordinates activities with other functional groups to

ensure timeliness and quality of project deliverables. This position reports to the Senior Director, Biometrics.

Essential Duties & Responsibilities but not limited to the following:

• This position reports to the Sr. Director and the head of Biostatistics within Clinical Development and will interact extensively with internal and external stakeholders directly contributing to and /or overseeing clinical study planning and analyses.

• Responsible for statistical aspects of assigned projects, including experimental design, protocol development, sample size estimation, patient randomization, case report form design, statistical analyses, and presentation of data.

• Ensures that project-related biostatistics and programming work is carried out in a timely and compliant manner.

• Expected to provide statistical expertise to new drug development programs as a Subject Matter Expert in Biostatistics and provides statistical leadership in the design of clinical development plans.

• Responsible for production of the following study-related deliverables: appropriate sections of study protocols, case report forms, statistical analysis plans, data analyses, manuscripts, and sections of clinical study reports and other registration documents.

• Responsible for the accuracy and completeness of statistical analyses conducted for assigned projects. Researches and applies new statistical procedures as needed. Prepares statistical summary reports as needed. Writes and/or reviews the statistical sections of protocols, clinical study reports, Summary of safety and efficacy documents.

• Establishes and maintains effective working relationships with vendors and project teams, including data management personnel, statistical programmers, clinical research personnel and corporate partners.

• Responsible for providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies.

• Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program. Monitors project progress and ensures proper resource allocation for successful project deliverables against goals and timelines.

Requirements:

• Possess a thorough understanding of the functioning of Biostatistics, Statistical Programming functional areas

• Thorough knowledge of statistical methodology, clinical experimental design and analysis for oncology therapeutic area.

• Substantial knowledge of one or more clinical subject matter area. Requires proficiency in SAS and an understanding of clinical data processing. Knowledge of other statistical and computational software packages (Splus, EaST, nQuery) is required.

• Knowledge of FDA and ICH requirements as they pertain to the analysis, presentation/reporting, and monitoring of data.

• Effective interpersonal skills and strong written and oral communication skills. The qualified applicant must also be flexible, well-organized, and have the ability to work well under pressure. Strong motivation to succeed.

• Knowledge of CDISC requirements for SDTM and ADaM;

• Prior experience contributing to content of INDs/NDAs/BLAs with eCTD formatted NDA/BLA submissions will be preferable.

Education: 

• Ph.D. in Biostatistics or Statistics with 4+ years of experience in biostatistics, with extensive experience within the pharmaceutical and/or biotechnology industries 

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

The Compliance Operations Senior Manager is responsible for supporting and collaborating with Medivation's Corporate Compliance Office and legal team to ensure Medivation's adherence to all applicable federal and state laws as well as all policies and regulations related to Medivations business practices.  Included in these responsibilities are the management of Medivation's transparency initiatives (Sunshine Act + various state requirements), coordination of training activities with the commercial Training group, serving as a liaison to the Marketing, Sales and Medical Affairs teams as necessary, participating in policy development and amendments, and management of technology related compliance initiatives. Additionally, the role supports all field and corporate personnel in health care professional interactions including system support, inquiry support and customer support.

Essential duties & responsibilities but not limited to the following:

Operations/Reporting:

• Responsible for timely and accurate submissions of all transparency reporting

• Quarterly data review and issue resolution

• Final report  (various state and federal) verification

• Interfacing with vendor to ensure completeness, accuracy, and timeliness of data

• Responsible for ongoing management of resources (internal or external) dedicated to transparency reporting

• Partnership with IT in implementing systems to support Medivation Compliance related technology initiatives

• Lead or participate in cross -functional data initiatives with customer and peer groups.  (Sale Ops, IT, Marketing, Sales, Legal)

• Provides day-to-day operational support for senior Commercial Ops staff in the following areas:

• Ongoing status of all transfer of value data

• Communication development for all compliance related activities

• Management of training and certification processes

• Training material development

• Auditing of field activities

• Sunshine Act Preparedness and Operational Management

Field Support:

• Provide ongoing updates on compliance with policies related to transparency, institutional requirements, data, etc…

• Triage and address issues submitted

• Assist with resolution of transparency related discrepancies

• Provide clarifications related to policy

Vendor Management – (CIS,...)

• Manage Vendor and deliverables to ensure timely and accurate transparency reporting

• Responsible for budget allocation of vendor product or services.

• Management of the Statement of Work by vendor.

• Supervision of deliverable and timelines.

• Coordinate on-going training and client site visits.

Qualifications

• 3-7 years biotech / pharmaceutical experience in pharma compliance/sales ops/data management or commensurate legal experience plus industry experience

• Supervisory or management experience desireable

• Experience with industry data and caveats

• Experience working with field teams and commercial organizations

• Ability to assemble a wide variety of data, translate it into information, and communicate a summary of the information. 

• Strong communication skills, strong analytical and problem solving skills, and intermediate computer skills.  Computer skills should include but not be limited to Excel, Word, and Power point.  Ability to resolve complex issues with the sales force.  Ability to work effectively within a fast paced team environment is essential.

• Specific product knowledge in the pharmaceutical or biotechnology industry is a plus. 

Education:

• Bachelors Degree is preferred (general business, economics, mathematics, statistics, or industry-specific, such as health sciences, disciplines are a plus)

• MBA or other related graduate-level degree is a plus

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publically traded biopharmaceutical company located in San Francisco.  We are currently seeking a qualified, highly motivated  and experienced individual for a Payroll Specialist.  This will be a temporary to permanent position.  Responsibilities will range from report creation, administrative duties and employee service associated with payroll.

Essential duties & responsibilities but not limited to the following:

• Perform day to day processing of multi-state 3 semi-monthly payrolls using ADP WorkForceNow.

• Maintain an ongoing relationship with ADP to ensure records are accurate

• Data entry of various payroll transactions including new hires, terms, garnishments, and benefit deductions

• Maintain PTO tracking and accruals

• Prepare manual checks as needed

• Answer employee inquiries about pay and benefits

• Prepare payroll journal entries

• Verify tax calculations of stock options

• Maintain and update payroll files

• Prepare special reports as needed

• Assist in special projects as assigned by management

Requirements

• Minimum 3-5 years experience with extensive payroll processing is required

• ADP payroll processing experience( WorkForceNow a plus)

• Strong knowledge of multi- state payroll processing

• Solid understanding of payroll tax laws

• Able to maintain confidential information

• Proficient with Excel

• Clear and effective written and verbal communication

• Able to prioritize tasks

• Works well in a team environment

• Detail Oriented

• Experience with ERP (Great Plains a plus)

• Stock Options processing

Education

• Bachelors or Associates Degree

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publically traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Manager, Clinical Finance, reporting directly to the Director, Finance.

The Senior Manager is responsible for all Finance aspects of our clinical trial activities including accounting and reporting.

Essential duties & responsibilities but not limited to the following:

• Manage day-to-day activities of Clinical Finance including contract review, clinical accruals/payments as well as the accounting and reporting of clinical related accruals and expenses

• Act as the primary liaison with Clinical Business Operations and subject matter expert in all financial aspects of clinical trials

• Review complex Excel models in tracking activities of all clinical trials to ensure data integrity, accuracy and completeness

• Review month-end journal entries and account reconciliations

• Develop reports and analysis of clinical trial accruals and expenses

• Maintain strong internal controls to ensure SOX compliance

• Provide leadership to the Clinical Finance team through coaching, performance management and aligning work priorities

• Build and maintain effective partnership with Clinical Business Operations, clinical project managers and others within the organization

• Drive continuous improvement efforts and initiate enhancements, both process and system related

• Assist with monthly/quarterly reviews and audits

Requirements:

• Minimum of 10 years of accounting experience, including at least 4 years in clinical trial accounting.  Public accounting experience is preferred and experience in a publicly traded company is required.

• Excellent problem solving and analytical skills

• Detailed oriented while maintaining broad business perspectives

• Effective communication skills, both written and verbal

• Strong team building and leadership skills

• Ability to work effectively with all levels throughout the organization

• Must be proactive and possess the ability to work independently

• Highly motivated and committed to driving changes and improving processes

• Advanced Excel skills; GP proficiency preferred

Education:

• BS/BA in Accounting; CPA required

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publically traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Accountant, Clinical Finance, reporting directly to the Senior Manager, Finance.

The successful candidate should have good general accounting knowledge, analytical, organization and communication skills.  Advanced Excel user preferred.  Responsibilities include month-end accruals, clinical model maintenance, account reconciliations, accounts payables, purchase orders and audit lead schedules preparations. 

Essential duties & responsibilities but not limited to the following:

• Track and update clinical activities, milestones and timelines in Excel models for the assigned clinical trials

• Prepare monthly clinical accruals & reconciliations and ensure that they are accurate and timely

• Review vendor invoices/payments to ensure proper coding and that they meet contractual terms and obligations

• Maintain effective partnership with Clinical Business Operations, clinical project managers and others within the organization

• Communicate with clinical vendors for month-end accruals

• Perform variance analysis for the assigned trials

• Ensure proper documentation and support for SOX compliance

• Prepare summary for material contracts

• Assist in quarterly and annual audits

• Identify and participate in process and system enhancements

Requirements:

• 5-7 years of accounting experience, including at least 3 years in clinical trial accounting.  Public accounting experience is preferred and experience in a publicly traded company is required.

• Excellent problem solving and analytical skills

• Attention to details and adept at managing priorities

• Effective communication skills, both written and verbal

• Must be proactive and able to work independently as well as in a team-oriented environment

• Advanced Excel skills is required; GP proficiency preferred

Education:

• BS/BA in Accounting; CPA preferred

Medivation, Inc. (NASDAQ: MDVN—www.medivation.com) a publicly traded biopharmaceutical company located in San Francisco, California, is currently seeking a qualified, highly motivated individual for the position of Stock Plan Administrator, reporting to the Associate Director SEC Reporting and Technical Accounting.

Stock Plan Administrator will be responsible for managing the daily administration of Medivation’s Equity Incentive Plan and Employee Stock Purchase Plan.  Working closely with Finance, Human Resources, Legal, and Merrill Lynch, this role will ensure the integrity of the data in EASi and Merrill Lynch Benefits Online.

Essential duties & responsibilities but not limited to the following:

• Manage all aspects of Medivation’s equity incentive plan and employee stock purchase plan, including the following:

• • Significant role in leading the transition of equity administration function from third party to in-house

  • Coordinate development of Black-Scholes assumptions with third party valuation consultant

  • Maintain the integrity of Medivation’s Equity Incentive Plan by processing data feeds, importing files and reconciling all activity in EASi (new grants, purchases, exercise, RSU vesting, cancelations, demographic changes, terminations)

  • Continually audit to ensure that data in EASi is aligned with data in Merrill Lynch Benefits Online broker platform

  • Work closely with Accounting department in providing supporting schedules for ASC 718 accounting entries

  • Manage the annual RSU lapse process

  • Work closely with Human Resources on new hire and annual grant processes, creating/reviewing requested reports, analysis and supporting materials

  • Coordinate entry for all daily option exercise income and annual RSU lapse income into ADP payroll

  • Manage administration of Employee Stock Purchase Plan (2 annual purchases/enrollment periods), including reporting for ASC 718 valuation

  • Reconcile common shares outstanding to transfer agent

  • Provide timely and accurate reporting to support Medivation’s, annual report, proxy statement, federal and state income tax filings, SEC filings, payroll and Sarbanes-Oxley (SOX) testing

  • Maintain desktop procedures and adhere to SOX controls

  • Interact with external auditors and SOX auditors in support of quarterly review, annual audits and SOX control testing and process documentation

  • Perform other ad hoc/ special projects as assigned

  • Manage ad hoc employee stock plan requests in a timely and professional manner

Requirements

• 5+ years experience in Stock Administration

• Superior analytical and advanced Excel skills

• Level 1 or Level 2 certified Equity Professional (CEP) designation preferred

• Technically skilled in EASi and Merrill Lynch Benefits On-Line

• Understanding of entire equity process cycle, including interdependencies between Legal, Tax, Treasury, Accounting, Payroll, and Human Resources

• Competencies

• Strong technical knowledge of stock compensation

• Exceptional attention to detail

• Proven ability to work well in a deadline-driven, fast-paced environment and ability to adjust to changing priorities

• Promote teamwork by working collaboratively with colleagues

• Strong customer focus and ability to effectively interact with all levels of management and employees

• Demonstrated ability to communicate clearly, concisely, and effectively to express information both written and oral context

Education:

• Bachelors degree in related discipline (Accounting/ Finance Preferred)

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 Tax.

This position will be responsible for establishing and leading the tax function for Medivation in our first year as a commercial company, following FDA approval of our lead product, XTANDI. This position will be directly responsible for managing corporate and subsidiary tax policies, procedures and filings. Additionally, this position is a senior finance position expected to contribute to a variety of strategic projects led by the VP of Finance.

Duties & Responsibilities but not limited to the following:

• Develop and lead the implementation of global tax policies and procedures in close coordination with the finance function, designed to optimize Medivation’s effective tax rate and minimize tax risk

• Manage the outsourced tax provision process under ASC 740 for our audited financial statements

• Manage preparation of R&D Tax Credit and Orphan Drug Credit Studies to optimize tax benefits associated with R&D Tax Credits and Orphan Drug Credits

• Provide tax advisory services and support to other functional and business units (including payroll, human resources and accounting).

• Develop and implement strategies to ensure full utilization of tax carryforwards

• Ensure that business transactions (acquisitions, dispositions, joint ventures, collaborations) are implemented in a tax efficient manner

• Review consolidated corporate federal and state income tax returns

• Manage our legal entity structure from a tax planning and compliance perspective

• Analyze and maintain optimal capital structures for all subsidiaries

• Manage transfer pricing planning and compliance in close coordination with other finance functions

• Manage indirect tax (S/U tax / VAT) planning and compliance

• Oversee income tax examinations and audits

• Manage external legal and tax advisors and service providers

• Other duties and special projects as assigned

Requirements:

• 10+ years of relevant tax experience, including at least 5 years of public accounting experience required

• Working knowledge of  the following tax areas:

• • Accounting for Income Taxes under ASC 740

  • Extensive knowledge of FIN 18& FIN 48

  • IRC Section 382

  • Intangible property structuring

• Mergers and Acquisitions and purchase accounting

• Experience with Transfer pricing arrangements 

• Previous experience managing, supervising and reviewing work performed by others (third parties)

• Education/Training: Bachelor’s degree in Accounting or Finance required.

Preferred Qualifications:

• 12 years of relevant experience in tax (treasury a plus)

• Significant experience in a multi-national tax program for a public company, including supervisory experience, preferably in the life science industry

• Excellent tax and US GAAP accounting skills

• Strong understanding of multinational enterprises, consolidated tax groups and tax planning concepts

• Excellent analytical and decision-making skills

• Superior communication and presentation skills

• Excellent writing and editing skills

• Strong commitment to business ethics

• Understanding of, and experience with, regulatory framework applicable to interactions with HCP's, payers, advocacy and other business partners

• Bachelor's degree and a Master's degree in taxation or comparable advanced degree

• License/Certification: Master of Taxation Preferred

• Travel – 10% of the time

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

Essential duties & responsibilities but not limited to the following:

• Oversee day-to-day activities of General Accounting including:

• • contract review and expense accruals for commercial, G&A and various R&D functions (pre-clinical, medicinal chemistry, CMC and regulatory/QA)

  • Cash, fixed assets, intercompany, payroll accounting, debt and others

• Manage and streamline monthly/quarterly financial close process; ensure the accuracy, completeness and timeliness of all relevant accounting transactions

• Review month-end journal entries and account reconciliations

• Develop reports and analysis of accruals and expenses

• Maintain strong internal controls to ensure SOX compliance

• Provide leadership to the General Accounting team through coaching, performance management and aligning work priorities

• Build and maintain effective partnership with all levels in the organization

• Drive continuous improvement efforts and initiate enhancements, both process and system related

• Assist with monthly/quarterly reviews and financial/SOX audits

Requirements:

•  Minimum of 10 years of accounting experience, including at least 4 years in general accounting.  Public accounting experience is preferred and experience in a publicly traded company is required.

• Excellent problem solving and analytical skills

• Detailed oriented while maintaining broad business perspectives

• Effective communication skills, both written and verbal

• Strong team building and leadership skills

• Ability to work effectively with all levels throughout the organization

• Must be proactive and possess the ability to work independently

• Highly motivated and committed to driving changes and improving processes

• Strong Excel skills; GP proficiency preferred

Education:

• BS/BA in Accounting; CPA required

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

The Director, Corporate Services will direct all services related to real estate, facilities operations and expansion for office space in San Francisco (currently 86,000 square feet) as well as our Commercial offices in Oakbrook, Il.  (currently 15,00 square feet) and all future offices.  They will work with key stakeholders in the Field and Corporate Headquarters to improve existing programs (i.e., EH&S, Travel ) as well as to design new programs (i.e., Purchasing) to benefit all employees.

The position will initially have five direct reports and will also provide hands-on technical support as required.

Essential Duties & Responsibilities but not limited to the following:

Real Estate

• Lead strategic planning for space expansion needs, including working with other departments to forecast space requirements.

• Act as lead with company’s landlords, real estate brokers and real estate attorneys on all lease negotiations.

Facilities and EH&S

• Direct project management and coordination of all tenant improvement projects.

• Develop and oversee maintenance programs and all operational services for two sites.

• Lead physical safety efforts and formalize required programs related to EH&S, including emergency response activities and ergonomic programs.

• Initiate and lead compliance with all regulatory agencies including:  CAL/OSHA, OSHA, FDA, EPA, local bodies: fire, city licensing.

Travel

• Direct and grow travel program:  including corporate credit card program, travel agency and compliance with policies associated with expense reimbursement system.

Purchasing

• Create and implement plan to address short-term improvements for Purchasing processes as well as develop a longer-term strategy for a larger program to support redesigned Procure to Pay processes.

Requirements:

• 10+ years experience as a leader in at least two of the essential duties areas.

• Strong business sense and understanding of the evolving business model.

• Demonstrated strength in leadership, judgment and initiative.

• Ability and desire to work cross-functionally to drive change.

• Proven capabilities to set priorities, drive results, and act efficiently and effectively within a complex business and organizational environment.

• Excellent written and verbal communication skills.

• Strong negotiating skills.

Education:

• Bachelor’s degree

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 Stability Manager. 

As a member of the PharmOps Team, reporting to Director of Analytical Chemistry, the Stability Manager will be responsible for monitoring the day to day stability studies of API, drug products, and other materials at Medivation’s contract manufacturer organizations (CMO) and contract research organizations (CRO). 

Essential Duties & Responsibilities but not limited to the following:

• Participate in the design of stability studies in support of new marketing applications.

• Track CMO/CRO activities and ensure stability testing timepoints occur according to protocols.

• Track stability data, stability reports, investigation reports, and other documents

• Compile data generated by CMO/CRO and carry out data analysis.

• Ensure that all the documents generated at vendors are fully and accurately completed

• Assist in preparation of  other internal document such as specifications, change controls and development reports

• Support R&D, QA, and Regulatory Affairs as needed

• Work and communicate effectively with internal and external team members

• Other activities as requested

Requirements:

• 5 years experience in a GXP research laboratory environment, analytical testing and documentations, and familiarity with Microsoft Office

• Experience in working with CMOs in a virtual environment Direct GMP experience with HPLC, GC, UV, wet chemistry, or spectroscopic testing

• Ability to review protocols and track samples, stability data, and reports

• Familiarity with spreadsheets and statistical analysis of analytical data

• Interact positively with other department members and vendors

• Self motivated with good organization skill

• Good communication and interpersonal verbal and written skills

Education:

• Bachelor Degree in a chemistry, biochemistry, biology, or pharmaceutical related field

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publically 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 small 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 intelligence, logical thinking, ability to prioritize day-to-day and critical tasks, “can-do” attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal and team building skills.

Essential Duties & Responsibilities but not limited to the following:

• Review and track study Trial Master Files (TMF) and submit documents to central records for storage

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

• Maintain and enter clinical study details into Medivation’s Clinical Trial Management System (CTMS)

• Responsibility for creating and maintaining documents, tables, databases, spreadsheets and files as needed

• Attend meetings, take and distribute meeting minutes

• Assist CRAs with preparing study binders, contact lists, site manuals and other study tools and templates, as directed

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

• Assist CRAs  by maintaining inventory of clinical supplies and purchasing study supplies, as directed

• Assemble and ship supplies to sites as directed. Prepare drug supply transmittals, track drug supply, and make appropriate arrangements for returned drug for all clinical projects

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

Requirements:

• Experience in clinical research is a must.

• Minimum of 2-3 years 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: work with limited supervision, 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.

Education: 

• BS or equivalent

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 Clinical Project Manager/Senior CRA.

The successful candidate will have the skills necessary to thrive in a fast-paced environment, as well as the ability to build a team and successfully manage the future growth of his/her function as the Company expands.  Particularly important skills include intelligence, logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal and team building skills.

Essential duties & responsibilities but not limited to the following:

• Supervise and mentor junior CRAs and other operational personnel;

• Work with the medical monitor to develop protocols and all documents required to initiate and conduct clinical studies, including informed consent forms, investigator brochures, case report forms, study procedure manuals, etc;

• Select and manage external service providers

• Develop and manage the clinical project team to meet clinical trial timelines consistent with the company’s goals;

• Select study investigators and evaluate adequacy to perform research and meet study timelines;

• Manage studies to meet enrollment goals.

Requirements

• Relevant experience in clinical trial execution;

• Multinational Phase 3 experience is a plus and highly desired

• Strong knowledge of GCP and ICH guidelines 

• Must be willing to travel as required for the project; estimated travel ~25-30%

 Education:

• Bachelor’s degree plus six or more years of pharmaceutical clinical research experience; RN degree or a degree in a healthcare related field or the life sciences is desirable but not mandatory  

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

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

The Director Drug Safety provides clinical expertise in the review and analysis of clinical study safety information. S/He will participate in the review of individual SAE reports, prepares pharmacovigilance commentary and analysis, and in the preparation of safety evaluations in aggregate periodic reports. The Director, Clinical Drug Safety represents the Drug Safety department in safety-related discussions with clinical investigators, IRBs/ECs, Data Monitoring Committees and regulatory authorities. The Director, Drug Safety contributes to the ongoing risk/benefit analysis of investigational drugs in clinical development and of marketed products.

Essential Duties & Responsibilities but not limited to the following:

• Participation with senior management to establish strategic plans and objectives

• Contribute to a full range of pharmacovigilance (PV) activities for investigational product and marketed products,  including operational activities, cross-functional activities with other departments (e.g., Biometrics, Clinical Operations, Clinical Sciences, Regulatory, Sales & Marketing), quality systems, audits and inspections

• Contribute to and review Investigator’s Brochures, safety sections of clinical study protocols, single and aggregate expedited reports, and risk management plans

• Contribute to and review safety data exchange agreements with alliance partners and safety management documentation for studies managed under an alliance, as applicable

• Develop and implement Safety Management plans with respect to vendor management

• Contribute to quality management plans and a compliance program; identify and follow-up on corrective action plans arising from audits and inspections

• Oversee preparation, development, implementation and maintenance of company standard operating procedures and policies relating to pharmacovigilance and risk management to ensure compliance with ICH guidelines and applicable regulatory requirements

• Direct drug safety management oversight (clinical study case process flow, reconciliation with clinical database) for specific clinical trials, as requested

• Act as Company PV audit liaison, and communicate findings to senior management

• Maintain currency with applicable PV global regulations, and industry guidelines

• Provide clinical/medical case review, as required, for investigational SAE reports, including reviewing the source records, reviewing the case narrative for accuracy, reviewing MedDRA coding for appropriateness, identifying medically relevant queries, confirming event “expectedness” based upon the reference safety information and assisting drug safety staff in determining reportability

• Provide a company clinical/medical comment, including causality assessment for SAEs reviewed

• Create or review the Analysis of Similar Events for SUSARs subject to expedited reporting;

• Provide clinical input in signal detection and perform signal evaluation activities;

• Provide a clinical perspective at Safety Management Committee meetings;

• Contribute to meetings with Data Monitoring Committees, as requested

• Lead team members, including Drug Safety Coordinators, Drug Safety Associates, to facilitate efficient case processing and other designated Drug Safety departmental tasks

• Develop and conduct training as necessary

• Provide regular performance feedback as well as development and coaching to direct reports

Requirements: 

• A minimum of 6 years industry experience

• Project leadership/management skills preferred

• Experience writing clinical study reports, poster presentations, and manuscripts for publication in a scientific journal preferred

• Healthcare professional with clinical research or drug safety experience

• Experience writing pharmaceutical or health-related documents

• Knowledge of regulatory requirements

Education: 

• Post-graduate degree (MD, PharmD, DO)

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 

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

The Outsourcing Manager will oversee and lead activities related to the outsourcing of clinical services to Clinical Research Organizations (CROs) and functional service providers for Clinical Development.  He/she will ensure compliance with key processes and manage outsourcing team.  And have the ability to working independently as well as work collaboratively with cross-functional groups to ensure the most optimal solutions are achieved in alignment with department strategies.

Essential Duties & Responsibilities but not limited to the following:

• Establish processes and tools used to identify and select vendors used for clinical trial outsourcing

• Manages the contract negotiations with  Clinical Development service providers including all initial contracts and any subsequent change orders

• Conduct on an ongoing basis analysis of vendor performance to ensure compliance against contracted services.

• Identify and maintain lists of potential vendors which may be used for Clinical Development outsourcing

• Maintain current awareness of clinical outsourcing marketplace and industry trends

• Support Clinical Operations Team and Clinical Trial Team in managing vendor relationships on a day-to-day basis to ensure high-quality service delivery and to address/escalate issues as appropriate

• Serve as point of contact to the CROs and clinical vendors in resolving contract scope and budget issues.

• Support department budgeting manager in  creating department budgets

• Manage and mentor outsourcing staff

Requirements:

• Must have strong analytical, negotiating and business communication skills

• 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

• Proficient with word processing, spreadsheet and database software

• At least five (5) years of experience in drug development in a pharmaceutical industry or CRO

• Procurement expertise (preferably in clinical research or service procurement)

• Sound background of financial/controlling issues

• Clinical Trial Management a plus

Education:

• Degree in Life Sciences (e.g. Biology, Chemistry, Pharmaceuticals) or business degree or equivalent

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

The Senior/Director, Clinical Development will work in a project team environment, primarily on ongoing or planned prostate cancer trial providing needed medical support to the study.  Internally, s/he will interface directly with clinical operations, regulatory affairs, biometrics, medical affairs, and other physicians within clinical development to ensure proper design, monitoring, and oversight of clinical trials.  Externally, s/he will be a liaison to investigators and key opinion leaders and participate in reporting and presenting clinical trial data.

Essential Duties & Responsibilities but not limited to:

. 

• Serving as medical monitor with primary responsibility for patient safety and conduct of assigned trials as well as overall data and safety surveillance

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

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

• Providing strategic input into clinical/regulatory development plans

• Writing/reviewing clinical trial protocols, study reports, and international regulatory documents

• Participating in the selection and management of contract research organizations (CROs) and other vendors

• Working actively with the study team reviewing study data and ensuring data quality

Requirements:

• Prior industry medical monitoring experience with knowledge of GCP, clinical trial conduct, and data interpretation.

• A minimum of 6 years industry experience

• Excellent verbal and written communication skills

• Ability to work collaboratively in a dynamic environment

Education: 

• MD Required; training in urology or oncology preferred

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

The Senior CRA will be responsible for managing the full scope of clinical operations (protocol development to final report, regulatory filing and/or publications) and coordinating cross functional efforts in the administration and progress of a clinical trial(s) in order to achieve study objectives and corporate goals. 

Essential duties & responsibilities but not limited to the following:

• Assist in managing all 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 of planning, implementing, monitoring and managing clinical trials;

• Provide supervision and guidance, clinical trial management expertise and direction to in-house and contract CRAs and CROs;

• Analyze/report safety issues, patient care issues, and study design and/or study conduct issues

• Participate in the design and development of clinical trial protocols and case report forms

Requirements:

• 8-12 years industry experience in drug development

• Oncology experience

• Proven ability for success in leadership position, including fiscal responsibility

Education:

• BS/BA in Life Science or related discipline

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

The successful candidate will have the skills necessary to thrive in a small 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 intelligence, logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal and team building skills.

Overall responsibilities for managing the full scope of clinical operations (protocol development to final report, regulatory filing and/or publications) and coordinating cross functional efforts in the administration and progress of a clinical trial(s) in order to achieve study objectives and corporate goals. 

Essential functions include but are not limited to the following:

• 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 and monitoring of clinical trials

• Oversee drug accountability at investigator sites and assist with the projection and management of both clinical and non-clinical supplies

• Assist in the preparation of clinical study reports, annual reports, IND updates, etc…

• Prepares and updates study drug forecasts

• Works with Medical Monitor and CPM to select investigative sites, train investigators and investigative site staff, preparation of materials for investigator meetings, clinical supplies

• Maintains study timelines.  Identifies and communicates study issues that will impact budget, resources and timelines. 

• Reviews and critiques CRF for accuracy and completeness.  Oversees data discrepancy management and assists with mapping as needed

• Provides training to internal and external customers as needed

• Makes recommendation on appropriate study vendor(s) to Director or CPM and manages vendor to achieve project goals

• Ensures that supportive study documents are completed (e.g., IVRS, specific scripts, non-clinical supply materials)

• Contributes to wider organizational goals and/or activities as assigned.

Requirements:

• 5-10 years industry experience in drug development

• Oncology experience required

Education:

• BS/BA in Life Science or related discipline; or equivalent experience

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 Director, Clinical Development, Oncology.

The Director, Clinical Development will work in a project team environment on clinical trials evaluating a novel therapeutic for Oncology. Internally, s/he will interface directly with clinical operations, regulatory affairs, biometrics, medical affairs, and other physicians and scientists to ensure proper design, monitoring, and oversight of clinical trials.  Externally, s/he will be a liaison to investigators and key opinion leaders and participate in the interpretation and presentation of clinical trial data.

Essential duties & responsibilities included but are not limited to the following:

• Providing strategic input into clinical and regulatory development plans for a therapeutic in oncology

• Developing clinical trial protocols that support the strategic context of the therapeutic

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

• Overseeing execution of clinical trial protocols, serving as medical monitor with primary responsibility for conduct of assigned trials including collection and interpretation of data and patient safety surveillance

• 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 and management of contract research organizations (CROs) and other vendors

• Collaborating with pre-clinical and translational medicine colleagues in assessing the potential of new compounds for development

Requirements

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

• A minimum of 3 years industry experience with at least 2 years in oncology development, preferably in breast cancer development

• Excellent verbal and written skills

• Ability to work collaboratively  in a dynamic environment

Education 

• M.D./D.O. degree required, sub-specialty and board certification in oncology 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

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, Clinical Development reporting directly to the Vice President, Clinical Development.

The Director/Senior Director, Clinical Development will work in a project team environment, primarily on late phase clinical trials of a novel therapeutic in the oncology arena. This position will initially serve as a medical monitor for a landmark Phase 3 prostate cancer study and subsequently play a key role in the preparation of regulatory submissions for approval both in the US and Europe.  Additionally, this position may also be involved with the design and initiation of other oncology studies.  Internally, s/he will interface directly with clinical operations, regulatory affairs, biometrics, medical affairs, and other physicians within clinical development to ensure proper design, monitoring, and oversight of clinical trials.  Externally, s/he will be a liaison to investigators and key opinion leaders and participate in reporting and presenting clinical trial data.

Essential duties & responsibilities but not limited to the following:

• Serving as medical monitor with primary responsibility for patient safety and conduct of assigned trials as well as overall data and safety surveillance

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

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

• Providing strategic input into clinical/regulatory development plans

• Writing/reviewing clinical trial protocols, study reports, and international regulatory documents

• Participating in the selection and management of contract research organizations (CROs) and other vendors

• Working actively with the study team reviewing study data and ensuring data quality

Requirements:

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

• A minimum of six years industry experience

• Excellent verbal and written communication skills

• Ability to work collaboratively in a dynamic environment

Education:

• M.D. degree required, board certification and/or additional training in urology or oncology 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

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

The Clinical Business Operations Contracts Assistant will support Clinical Business Operation with clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials.

Essential Duties & Responsibilities but not limited to the following:

• Provides various clerical activities to support CBO Contracts team

• Assist in status tracking of all site agreements and budgets

• Enter site financial obligations into CTMS

• Process Site startup payment

• Process and track site agreement amendments and terminations letters

• Manage status updates to internal/external groups

• Online courier services

• Attend all dept meetings

• Negotiate and prepare initial contracts and amendments for NA/*Global programs

• Stay up to date on internal and external processes and industry costing requirements

• Participate SMT meetings

• Implement and streamline contract activities

Requirements:

• Entry-Advance level knowledge of word processing, spreadsheet, and database software and with filing systems

• Experience in clinical research / exposure to contract activities

• Must be self-motivated and be able to: work with limited supervision, 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

• Experienced with filing systems

• Strong Communication skills, written and verbal for interactions with global clinical sites; ability to communicate without direct oversight by manager

Education: 

• Bachelor’s degree preferred or relevant experience

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 Clinical Project Manager for Breast.

The successful candidate will have the skills necessary to thrive in a fast-paced environment, as well as the ability to build a team and successfully manage the future growth of his/her function as the Company expands.  Particularly important skills include intelligence, logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal and team building skills.

Essential duties & responsibilities but not limited to the following:

• Supervise and mentor junior CRAs and other operational personnel;

• Work with the medical monitor to develop protocols and all documents required to initiate and conduct clinical studies, including informed consent forms, investigator brochures, case report forms, study procedure manuals, etc;

• Select and manage external service providers

• Develop and manage the clinical project team to meet clinical trial timelines consistent with the company’s goals;

• Select study investigators and evaluate adequacy to perform research and meet study timelines;

• Manage studies to meet enrollment goals.

 Requirements

• Relevant experience in clinical trial execution;

• Multinational Phase 3 experience is a plus and highly desired

• Oncology experience

• Strong knowledge of GCP and ICH guidelines 

• Must be willing to travel as required for the project; estimated travel ~25-30%

Education:

• Bachelor’s degree plus six or more years of pharmaceutical clinical research experience; RN degree or a degree in a healthcare related field or the life sciences is desirable but not mandatory  

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

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

The document control assistant is responsible for ensuring that all clinical trial related documentation is archived appropriately and that documents are handled and stored according to department SOPs and GXP regulations. 

Essential Duties & Responsibilities but not limited to the following:

• Review incoming materials in order to determine how and where they should be classified or filed,

• Operate mechanized files that rotate to bring needed records to a particular location,

• Assist in the development of  forms related to filing systems,

• Find and retrieve information from files in response to requests from authorized users

• Perform periodic inspections of materials or files in order to ensure correct placement, legibility, and proper condition,

• Assist other departments with development and maintenance of their files

Requirements

• 1-2 years of direct filing experience

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

• Familiarity with word processing, spreadsheet and database software

• Good 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.

Education: 

• High School Diploma

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publically traded biopharmaceutical company located in San Francisco.  We are, currently seeking a qualified, highly motivated, experienced individual for the position of Clinical Research Associate II/III (Breast).

The successful candidate will have the skills necessary to thrive in a small 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 logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal and team building skills.

Essential functions include but are not limited to the following:

• Assist in 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 and monitoring of clinical trials

• Oversee drug accountability at investigator sites and assist with the projection and management of both clinical and non-clinical supplies

• Assist in the preparation of clinical study reports, annual reports, IND updates, etc

• Prepares and updates study drug forecasts

• Works with Medical Monitor and study team to select investigative sites, train investigators and investigative site staff, preparation of materials for investigator meetings, clinical supplies

• Reviews and critiques CRF for accuracy and completeness

• Oversees data discrepancy management and assists with mapping as needed

• Provides training to internal and external customers as needed

• Makes recommendation on appropriate study vendor(s) to study team and manages vendor(s) to achieve project goals

• Ensures that supportive study documents and plans are completed per Medivation Standard Operating Procedures or best practicies

• Contributes to wider organizational goals and/or activities as assigned

Requirements:

• 2-5 years industry experience in drug development, including site monitoring experience

• Oncology clinical trial experience preferred

Education:

• BS/BA in Life Science or related discipline

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

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

The Clinical Development medical writer will participate in the development of a variety of key clinical and regulatory documents across therapeutic areas and throughout the product lifecycle.  

Responsibilities include but are not limited to the following:

• Plan, organize, and manage tasks related to the development of clinical and regulatory documents such as phase 1–4 protocols, clinical study reports, investigator brochures, informed consent forms, patient narratives, statistical analysis plans, independent committee charters, briefing packages; INDs and updates; NDAs, and regulatory responses

• Collaborate with multidisciplinary team members to develop and manage project timelines; ensure that timelines are met and that documents are completed according to Medivation standards and processes

• Ensure consistency of documents within and across clinical programs by managing content and developing and maintaining document standards, styles, and templates

• Participate in SOP development and review

Requirements:

• Knowledge of the drug development process and regulatory requirements for documents including applicable regulations, ICH guidance, and GCP standards

• Minimum 2 years experience as a clinical/regulatory medical writer in a biotechnology or pharmaceutical company required; oncology experience preferred. 

• Advanced skills in researching, writing, editing, reviewing, and managing clinical and regulatory documents

• Ability to organize, integrate, summarize, and present scientific and clinical data and information from a variety of primary sources in an accurate, clear, concise, and consistent manner for a variety of audiences

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

• Strong record of collaborative multidisciplinary teamwork and innovative problem solving

• Knowledge of AMA style, medical terminology, and clinical data analysis

• Proficiency in organization and project management

• Exceptional skills related to using Microsoft Word to generate complex documents

• Outstanding attention to detail, goal oriented with assigned tasks, self–motivated, professional and friendly demeanor, flexible, accommodating

Education / Experience:

• Bachelor’s degree in a science discipline (advanced degree preferred) or degree in medicine such as RN, PharmD, or MD. 

• AMWA member with certificate preferred; BELS certification a plus.  Position level and responsibilities will be commensurate with education and experience. 

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 HR Business Partner, reporting directly to the Director of Human Resources.

The HR Business Partner will be responsible for developing, implementing, and driving the people strategy and agenda that meets the objectives and the long term strategic vision of the organization. This role will be responsible for leading the HR support for a defined client group within our San Francisco corporate headquarters.

The successful candidate will have broad-based business experience in aspects of human resource management. 

Specific performance and behavioral competencies include:

• Business acumen

• Analytical and critical thinking

• Influencing skills

• Ability to apply structured thinking and methodology to frame problems and find solutions

• Resourceful and innovative; always pushing to find new and better ways of working

• Balanced approach to serving local business needs while advocating corporate objectives

• An excellent listener and communicator, this person must develop collaborative relationships within a diverse group of leaders with varying styles. Must be able to work through a matrix management environment with both business leaders and HR peers.

Essential duties & responsibilities but not limited to the following:

• Serve as HR Partner to key stakeholders within an assigned client area; building strong credibility and trust are essential to the role.

• Assists the HR leadership team in developing and implementing organizational strategies and plans.

• Executes changes that increase organizational effectiveness and/or optimize efficiency, and works with line leaders and appropriate internal or external organizational development support to effectively implement changes to structure or culture, as the organizations needs determine.

• Works with the staffing team to develop appropriate staffing strategies for their client areas and ensures that policies and procedures are aligned with effective recruiting results

• Works with the compensation team to ensure that compensation policies are in alignment with corporate programs and policies.

• Responsible for certain aspects of the human resource planning process and will initiatives to drive teamwork, organizational effectiveness, continuous process improvement, and effective communication at lower levels in the organization.

• Play an important role in ensuring that human resource strategies and plans are consistent with overall business objectives.

• Responsible for building manager capability to lead the business and drive employee engagement.

• Facilitate and coach business leaders and their leadership teams regarding employee relation issues.

• May perform other related duties as required and/or assigned.

• Ensure compliance with all state and federal statutes and regulations including but not limited to all applicable wage and hour laws, and regulations related to, FMLA, OSHA EEO and ADA.

Requirements:

• Bachelors Degree in Business, HR, or relevant university degree

• 5-10 years experience in HR with the last few years as a strategic HR Business partner

• Strong knowledge of California and Federal employment regulations

• Prior experience in supporting senior business/functional leaders

• Strong customer relationship skills, ability to build strong relationships with senior level customers.

• Effective oral and written communication skills with the ability to communicate with employees at various organization levels, including senior management

• Ability to collaborate and work across a large, diverse, and matrixes organizations

• Ability to deal with ambiguous and fluid situations

• Biopharma experience preferred

• Broad-based experience that has required comprehensive analysis of complex situations, creative problem solving and strong influence skills

• User level working knowledge of HR information systems required

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, Compensation & HRIS, reporting directly to the  Director, Human Resources.

This role will be responsible for analytics across the HR organization in support of the business.  The Manager, HR Compensation and HRIS will assist with day-to-day reporting and ad hoc analysis, as well as play a key role in the merit review planning and coordination process, general compensation, surveys and benefits.  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 & Responsibilities but not limited to the following:

• Provide analysis and build/generate reports in support of compensation and reward programs, including regular merit performance review cycles, Compensation and Benefits Surveys and ad hoc reporting.

• Perform custom analysis and reporting to support HR and Business Partners

• Responsible for generating HR metrics, while providing insight and analysis on trends to drive more informed HR/business decisions, and process/quality improvement initiatives

• Responsible for reporting and analysis from various systems including ADP Payroll

• Assist in the ‘Big Picture’ management of Benefit Vendors including costing and comparison of competitive and new benefits.

• Leader/key player in HRIS Systems implementation including ADP, Onboarding, Applicant Tracking, Budget and other HRIS solutions.

• Play a key contributor role to various HR projects and functions including working on teams and collaboration with individuals across functions.

• Strong relationships with Sr. Business Leaders are required during the planning process and throughout the fiscal year.

• Utilize metrics and apply analytical skills to discern current plan effectiveness.

• Support governance processes to ensure that compensation practices are in alignment with the overall strategic intent.

• Liaison with the Human Resources, Finance, and Sales Operations teams to ensure that integrated support is provided to the client on compensation issues.

Requirements:

• 5-7 years of analytics experience required. Strong consultative skills and the ability to build solid relationships with the HR team, cross-functional internal partners and external providers/vendors

• Stellar written and verbal communication and presentation skills with attention to detail and service follow-up. Ability to work independently and be proactive in a high performance environment, possess a strong sense of ownership and accountability.  Must possess excellent business acumen.  A problem solver!

• Strong proficiency in Microsoft applications (PowerPoint , Word, Excel,); Expert in MS Excel and other business tools and software

• Familiar with HRIS tools and reporting capabilities

• Ability to generate accurate data, and to participate in the analysis and communication to a variety of audiences

• Understanding of current market strategies and compensation plan design techniques that creatively reward objectives and also respond to quickly changing business demands and marketplace trends

• Able to work independently with only minimal management participation, with proven leadership and influencing skills

• Exceptional written communication and presentation skills

• Effective project management skills required

• A solid quantitative and analytical background

• Certified Compensation Professional (CCP) is preferred.

• Highest professional ethics and professional presence including the unwavering maintenance of business and employee confidentiality

Education:

• Bachelor’s degree in Business Administration or related field, or commensurate experience required. Master’s degree desirable.

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

The Manager/Sr. Manager Talent Acquisitions is responsible to implement the organization’s recruitment plan by identifying and recruiting qualified candidates for open approved requisitions.  The role will have input into the creation of recruiting objectives. The selected candidate will provide expert level consultation, guidance and direction in sourcing and recruitment to the HR Directors and Hiring Managers.  Also, provide in-depth content expertise of development and/or implementation of sourcing and recruitment programs, policies and practices. The role will also assist in the tracking of budget resources consumed and in maintaining the accuracy of Position Control and Applicant tracking. The Talent Acquisition Manager 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 & responsibilities but not limited to the following:

• Manage the full-cycle recruitment process, including initial applicant sourcing, qualification assessments, interviews, and offers

• Work with VPHR, HR Directors and hiring managers to optimize recruitment efforts

• Identify and source qualified talent for current open roles Source, cold call, build relationships and network to generate successful placements

• 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 HR Directors prepare and negotiate job offers and relocation benefit packages where applicable

• In conjunction with HR Directors engage in vendor management and identification of recruiting resources.  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

• Develop relationships with third party recruitment agencies and staffing firms and manage the procurement process

• Work with management to maintain and track budgeted headcount, requisitions, and staffing reports/metrics

• 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: 

• 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 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

• Proficient with resume tracking and database programs

• 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’s degree or 8 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. EEO.

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publically traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior IT Business Analyst, Clinical Systems. 

As a member of the Information Systems team, the purpose of this role is to plan, design, configure, and deploy all clinical operations systems including Clinical Trials Management System (CTMS), MS SharePoint and other enterprise business systems in support of core organizational functions and processes. The analyst must be able to provide both application support in a business analyst capacity as well as technical support. This includes project management, software installation, and performing system administration functions. This individual will apply proven communication, analytical, and problem-solving skills to help maximize the benefit of IT system investments.

Essential Duties & Responsibilities but not limited to the following:

Strategy & Planning

• Collaborate in the planning, design, configuration, and deployment of new applications, and enhancements to existing applications

• Ensure that applications meet business requirements and systems goals, fulfill end-user requirements, and identify and resolve systems issues

• Lead projects from initiation through implementation and support in a GxP environment to meet business needs.

• Assess, provide solution options and recommendations to all levels of management

• Define project scope, goals and deliverables that support business goals in collaboration with senior management and stakeholders

Acquisition & Implementation

• Support the Clinical teams in oversight and management of clinical systems.

• Partner with IT and Data Management on all Clinical Systems integrations and upgrades

• Provide technical knowledge and expertise during the application installation.

• Collaborate with team members, designers, vendors, and system owners in the testing and validation of new software programs and applications.

• Ability to author, execute protocols, perform testing sequences and change controls.

• Collaborate with quality team to develop validation strategy and test plans.

• Ability to identify and resolve application incidents and requests or refer to other IT groups or vendor when necessary

• Experience with administering SharePoint site collections that support efficient business process workflows; including configuring and supporting workflow functions

• Design and develop portal content and applications that integrate with other enterprise systems and third party products

Operational Management

• Maintain (patch), repair and manage new and existing systems adhering to GxP process

• 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 clinical applications

• Liaise with network administrators and application analysts to assist with quality assurance, program logic, and data processing

• Identify and resolve system application issues

• Monitor help desk tickets on Clinical applications

Requirements:

• 3+ years direct experience managing enterprise applications and/or systems management with a focus on Clinical, Quality, and Research systems in a pharmaceutical or medical device industry.

• Proven experience in planning, installation and implementation of software solutions.

• Direct, hands-on experience with server administration tools.

• Excellent project management skills and/or substantial exposure to project-based work structures.

• Strong knowledge of Microsoft SharePoint administration and design development.

• Strong knowledge of authoring computer system validation documentation.

• Extensive experience with core software applications, including CTMS, eDMS, QMS.

• Working knowledge of network and Windows PC operating systems.

• Knowledge of applicable data privacy practices and laws.

• Life Sciences industry experience preferred; 21 CFR Part 11 compliance; Extensive experience with core software applications, including CTMS, eDMS, QMS; Working knowledge of network and Windows PC operating systems

Education: 

• Bachelors degree in MIS, computer systems design or computer science.

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publically traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Director of Enterprise Data Warehousing/Business Intelligence.

Reporting to Senior Director, IT, the Director of Enterprise Data Warehousing/Business Intelligence role is to plan and directs all aspects of the application and technical infrastructure to enable and deliver on the business priorities for Commercial, Sales and Marketing divisions along with developing enterprise wide Business Intelligence and Reporting capabilities. Oversee build-out, implementation and maintenance of commercial systems and ensures scalability and accessibility of applications and services.

Essential duties & responsibilities but not limited to the following:

• Works to understand and align corporate vision and business and reporting systems, especially for Commercial, Sales and Marketing

• Responsible for timely delivery of project initiatives. This is achieved through experience-driven vision and planning, hands-on work combined with external vendor management.

• Define functional requirements and work closely with business senior management in Commercial, Sales and Marketing. Translate into actionable plans for short-term and long-term

• Know the nuances of the business to drive enterprise process and optimization via IT

• Define metrics based on business objectives

• Establish and foster relationships with Business Stakeholders and service providers

• Oversee Application and reporting development

• Works to continuously improve effectiveness, efficiency and customer satisfaction (internal and external customers)

• Ensure corporate governance is included with business process via IT

• Guide and assist in documentation of IT policy requirements

• Integrate design and evaluate commercial systems relative to CFR 21 Part 11, HIPPA, Sunshine Act and SOX requirements

• Strong focus and experience on Analytics & Information Management

• Support information and data requirements for commercial teams; understanding compliance requirements with such activities

• Develop, track, and control the IT Commercial annual operating and capital budgets.

• Keep current with trends and issues in the IT industry, including current technologies and prices for Commercial, Sales, and Marketing. Advise, counsel, and educate executives and management on their competitive or financial impact.

• Act as an advocate for the organization’s IT vision via regular written and in-person communications with the organization’s executives, department heads, and end users as it relates to Commercial IT

• Assess and communicate risks associated with IT investments.

• Develop business case justifications and cost/benefit analyses for IT spending and initiatives.

• Coordinate and facilitate consultation with stakeholders to define business and systems requirements for new technology implementations.

• Strong people management and coaching skills are a must

• Ability to multi-task in a fast-paced, dynamic environment

Requirements:

• Ideal candidate has IT experience of taking a Biopharmaceutical company from pre-commercial stage through a successful launch and post-commercial activities.

• Strong communication skills (verbal and written); effective in interaction with executive management12+ years of relevant industry experience, including 10+ years in a leadership role.

• Strongly preferred Biopharmaceutical company experience in fast-growing, pre-launch, launch and post launch activities; commercial IT/data infrastructure background required.

• Successful track record of IT leadership, execution and delivery. Experience leading IT applications groups in applying innovative IT solutions in support of the business.

• Management experience in Commercial IT and Data Warehouse/Reporting. Proven experience in building out, training and leading an IT team; management experience with highly skilled IT individuals.

• Excellent management, leadership, organizational, communication and customer service skills with active-listening skills.

• Proven adaptability to shifting project schedules, priorities and assignments; able to make effective decisions under pressure.

• Demonstrated problem-solver with the ability to cope under pressure and coordinate multiple activities in a dynamic, fast-paced team environment.

• Ability to prioritize staff responsibilities based on criticality or business impact.

• Experience managing people and supporting staff in remote locations.

• Excellent interpersonal skills with the ability to interact with all levels of employees, vendors and partners.

• Excellent writing and documentation skills including proof reading and attention to detail.

• Experience working in a regulated networking environment (SOX and 21CFR11)

• Ability to work flexible schedule to include weekends and holidays

• Strong mentoring skills

• Experience in building and managing a team of strong technical and business people

• The individual must be a self-driven, motivated senior IT leader with strong analytical and problem solving skills, and leadership/good executive presence.

Education:

• Bachelor's Degree or an equivalent level of education and experience.

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

The Medical Director, Medical Affairs will be responsible for the successful execution of medical affairs programs and deliverables through partnership with the following functional areas: the Medical Science Liaison team, Scientific Communications, and the Clinical Development organization. Forging a productive and compliant partnership with the Commercial organization and with our Alliance partner, Astellas, will be essential. The candidate will report to the Senior Medical Director, Medical Affairs who, in turn, reports to the VP of Medical Affairs.

As a leader in the organization the incumbent will be accountable, along with the 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 the in leadership of the Investigator Initiated Trial Program; the establishment and maintenance of key global partnerships and collaborations; and global opinion leader relationship support.

Essential duties & responsibilities but are not limited to the following:

• Provide strategic leadership and management of the Investigator Initiated Trial program within scope, budget and timelines and through cross-company and cross-functional partnerships

• Facilitate and/or deliver scientific/medical information and clinical/research findings

• Provide Medical expertise to the Commercial Team to assist in the development and execution of compliant commercial activities

• Build strong relationships with the experts and advocates within the prostate cancer community

• Assist and lead advisory boards that are developed to seek input from the medical community

• Present medical information on the Company’s products at meetings with payer organizations

• Participate in the Company promotional materials review process

• Participate in the design and oversight of corporate sponsored medical affairs trials

• 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

The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent.

Qualifications/Requirements:

• Minimum of 3 - 5 years of experience and success within another biotech/pharmaceutical company, with 2 or more years in Medical Affairs

• Professional knowledge and skills working with oncology therapeutics and/or in prostate cancer is required

• Experience designing and implementing Phase 4 and Investigator Initiated Trials programs is required

• Prior experience with promotional materials review is required

• Experience partnering with Field Medical staff 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

Capabilities and Competencies

• Executive presence

• Values based collaborator – respectful, accountable and collaborative

• Ability to relate and work with a wide range of people to achieve results

• Impactful written and verbal scientific communication

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

• Problem solving and risk-mitigation skills

• Confident, positive attitude, enthusiastic and charismatic

• Appreciation of diversity and multiculturalism

• Strategic and creative thinker

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

• Strong time management and organizational skills

• Ability to manage multiple projects in a fast paced environment

• Willingness to travel extensively and globally

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

Education/Certifications/Licenses:

• Medical Degree or international equivalent 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

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

The Senior Director, Medical Affairs will be responsible for the successful execution of medical affairs programs and deliverables through partnership with the following functional areas: the Medical Science Liaison team, Scientific Communications, and the Clinical Development organization. Forging a productive and compliant partnership with the Commercial organization and with our Alliance partner, Astellas, will be essential. The candidate will report to the VP of Medical Affairs who, in turn, reports to the Chief Medical Officer.

As a member of the Medical Affairs leadership, the incumbent will share accountability to guide the medical affairs program strategy and assure high quality execution of medical affairs activities. The incumbent will also play a key role the in leadership of the publication activities; the establishment and maintenance of key global partnerships and collaborations; and global opinion leader relationship support especially in urology.

Duties & Responsibilities but not limited to the following:

• Provide medical and strategic leadership for publications activities through cross-company and cross-functional partnerships.

• Facilitate and/or deliver scientific/medical information and clinical/research findings.

• Provide Medical expertise to the Commercial Team to assist in the development and execution of compliant commercial activities.

• Build strong relationships with the experts and advocates within the urology community.

• Assist and lead advisory boards that are developed to seek input from the medical community

• Present medical information on the Company’s products at meetings with payer organizations.

• Participate as needed in the Company promotional materials review process.

• Participate in the design and oversight of corporate sponsored medical affairs trials.

• 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.

Requirements:

• Minimum of 5 - 7 years of experience and success within another biotech/pharmaceutical company, with 3 or more years in Medical Affairs.

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

• Professional knowledge and skills working with urologists is desired.

• Prior experience leading publication activities is required

• Prior experience with promotional materials review is required.

• Prior experience evaluating Independent Medical Education grants is desired.

• Experience partnering with Field Medical staff 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.

Capabilities and Competencies

• Executive presence.

• Values based collaborator – respectful, accountable and collaborative.

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

• Impactful written and verbal scientific communication.

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

• Problem solving and risk-mitigation skills.

• Confident, positive attitude, enthusiastic and charismatic.

• Appreciation of diversity and multiculturalism.

• Strategic and creative thinker.

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

• Strong time management and organizational skills.

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

• Willingness to travel extensively and globally.

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

Education

• Medical Degree or international equivalent required.

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 Clinical Study Assistant, reporting directly to the Director of Clinical Operations.

The Administrative Assistant position provides a variety of standard and advanced administrative support functions. Including direct support for department senior management and all around support for the remainder of the team. The individual must be self-motivated, have excellent interpersonal skills and the ability to build professional relationships. This individual must also 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 & Responsibilities but not limited to the following:

• Work with vendor work orders, purchase orders, and assist with invoice routing, coding, and tracking.

• Generate a variety of contract agreements with vendors and contractors, as well as process them in–house.

• Communicate and interact directly with our scientists located abroad.

• Assist with ordering laboratory and office supplies for our offsite laboratory.

• Obtain reference materials for the research group.

• Screen telephone calls, redirects calls, and respond to routine inquiries regarding department business.

• Schedule meetings, maintain calendars, and register group members for offsite seminars and conferences.

• Prepare domestic and international travel arrangements and accommodations.

• Process expense reports.

• Provide occasional back-up support to receptionist and other administrative staff as needed.

• Work collaboratively with other administrative staff.

Requirements:

• Proven experience handling confidential and sensitive information.

• Expertise in Microsoft Word, PowerPoint, Excel, and Outlook required.

• Must have excellent organization skills, high attention to detail, and a desire to get all work completed accurately and in a timely manner.

• A minimum of 5-7 years as an administrative professional.

Education

• High school diploma, GED, secretarial/business school certificate, college degree, or equivalent experience, desired.

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publically traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Manager/Associate Director, GCP QA, reporting to the Director, Clinical Quality Assurance (CQA). 

The role of the Senior Manager/Associate Director GCP QA is to provide proactive GCP Quality and compliance oversight and guidance to assigned functional areas and stakeholder groups within the Clinical Development organization. 

Essential duties & responsibilities but not limited to the following:

• Assist with development of the audit strategy and programs.

• Assure timely execution of approved audit programs and schedule.

• Provides oversight and directs training of CQA staff in all aspects of the quality management function; especially as it relates to conducting and hosting auditing..

• Identify/monitor GCP compliance risks;provide guidance on mitigation/management of such risks. 

• Lead and/or support GCP inspection readiness and inspection management activities.

• Represent CQA in Study Management Team, GCP Compliance Committee, and Clinical Quality System review and improvement teams.

• Monitor and maintain CQA operations within budget.

• Ensure timely development of audit schedule, assist in the preparation and conduct audits in support of all GCP activities as directed.

• In collaboration with the Director, CQA, ensure that appropriate Standard Operating Procedures are in place

• Manage and coordinate the activities of the audit teams

• Lead and/or participate in GCP site and vendor audits in accordance with Medivation standard operating procedures, quality policies and/or plans.

• Interpret policies, standards, and regulations, and applies to evaluation of  potentially critical problems Exercises sound and balanced judgment in evaluating compliance of quality systems, processes, procedures, and protocols.

• Appropriately and expeditiously escalate GCP compliance issues.

• Communicate audit results to management and auditees through written audit reports.

• Ensure key stakeholders are informed of non-compliances identified during audits.

• Manage post-audit follow-up on any necessary corrective and preventive actions; resolves any conflicts to closure

• Develop and manage periodic reports of key Clinical Quality metrics to management as requested.

• Assist with training/orientation/qualification of new CQAAuditing staff

• Travel required up to 35% as needed (travel may be domestic and international)

Requirements:

• Minimum of 8 to 10+ years’ experience in the pharmaceutical/biotechnology industry

• Minimum of 7+ years’ auditing in one of the following areas: GCP, GLP, GPvP

• Expert knowledge of technical concepts required for all aspects of GCP Auditing, to include all types of GCP audits; e.g., Study Sites, Vendors, essential study documentation

• Solid understanding of domestic and international pharmaceutical/Biotechnology auditing standards

• Extensive experience supporting regulatory authority inspections of clinical research activities

• Hands-on experience managing quality and compliance projects and programs

• Proven ability in driving quality process improvement initiatives.

• Extensive leadership experience and mentoring skills Thorough knowledge and application of international requirements of Good Clinical Practice (GCP) and ICH Guidelines

• Strong global knowledge and understanding of regulations applicable to the conduct of clinical trials

• Strong working knowledge of clinical development and operations

• Strong communicator with strong verbal, written communication and presentation skills

• Experience in providing training on key quality and regulatory compliance information

• Strong Partnering and collaboration skills

• Balance approach to issue management and mitigation planning

• Clinical Quality System and Clinical computerized systems; e.g., EDC, IxRS, etc.

• Accomplished knowledge of global and local GCP regulations

Education: 

• Bachelor of Science Degree or higher

• RQAP-GCP or other certifications are highly desirable

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 Regulatory Affairs, Advertising & Promotion.

The Director will work independently on the review of proposed concepts and projects as well as in a cross functional team environment, primarily comprised of senior legal, medical and marketing colleagues. The candidate will need to think creatively, bring new ideas to the table and have direct influence on the decision making processes within the scope of the advertising and promotion of marketed products.

Essential duties & responsibilities but not limited to the following:

• Foster cross-functional relationships and provide Regulatory guidance to internal customers.

• Train marketing and sales representatives on advertising and promotion regulations to ensure company-wide compliance.

• Communicate regulatory agency/industry positions to internal stakeholders

• Strategize with and advise internal stakeholders on regulatory issues

• Attend Materials Approval Process (MAP) meetings in person and provide regulatory expertise and guidance in the review of internal (e.g. sales training) and external (e.g. advertising/promotional) communication materials related to marketed products

• Communicate the impact of new, existing and pending regulations, guidelines and standards, and review committee recommendations to regulatory staff and internal stakeholders

• Establish SOPs, operating agreements and put in place key claims and safety statements to facilitate the review and approval process.

• Review and provide feedback on non-promotional scientific and medical information and external communication materials in the context of the Medical Affairs Review Committee (MARC) meetings

• Assess external communications relative to regulations

• Review publicly disseminated information to minimize regulatory exposure, review product claims and preserve confidentiality of applicable product information

• Notify, consult or brief legal counsel when appropriate

• Collaborate with co-development partner to develop best business practices for the review and approval of communication materials related to marketed products

• Participate and take leadership role in professional associations, industry/trade groups (local/regional/ international) and appropriate standards organizations in order to maintain an up to date understanding of the competitive landscape and how competitors are dealing with similar issues in advertising promotion and labeling

Requirements:

• Understand the current regulatory/compliance environment pertaining to prescription drugs, biologics and medical devices, both from an FDA and OIG/DOJ perspective

• Knowledgeable on the FDA advertising and promotional requirements, including such topics as: claim support requirements, fair balance expectations, internet challenges, product booths at medical conventions, disease state programs, and public relations challenges.

• Minimum 5 years of U.S. Advertising, Promotion, and Labeling experience at an advanced level in the pharmaceutical industry.

• Knowledge and Understanding of US regulations

• Proven ability to work as part of a team, as opposed to working separately or competitively within the group

Education:

• Bachelor’s degree required, advanced degree preferred

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 Regulatory Affairs Associate.

The Regulatory Affairs Associate supports a variety of activities in the Regulatory Affairs department related to regulatory submissions and systems. 

Essential Duties & Responsibilities but not limited to the following:

• Assist with the coordination, review and preparation of clinical trial applications, ensuring compliance with the Food and Drug Administration (FDA) and international regulations and interpretations

• Represent Regulatory Affairs on Study Management Teams (SMT) for the clinical development and clinical trials of investigational new products

• Review and approve documentation required for release of clinical supplies to clinical sites

• Coordinate regulatory sections and review IND annual reports/ DSURs, PADER/PSURs to ensure compliance with the Food and Drug Administration (FDA) and international regulations and interpretations

• Alert the Regulatory Management to issues and potential problems, delays and/or deficiencies, and make recommendations as appropriate

• Schedule, track project/operational activities, such as labeling reviews and approvals.

• Monitor various regulatory agency websites for new regulations, guidance documents and pertinent agency meetings

• Prepare Regulatory Standard Operating Procedures and Work Procedures

• Other Duties as assigned

Requirements

• Knowledge of FDA regulations. 

• Knowledge of foreign regulations and ICH is a plus.

• Experience in the preparation and submission of INDs, CTAs, and amendments.

• Able to review routine regulatory and scientific submission documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies.

• Excellent verbal and written skills

• Ability to prioritize  multiple tasks

• Attention to detail

• Must be able to work successfully within a cross-functional team/partnership environment and as an individual contributor, with a high level of professionalism.

• 4 years of industry experience working in pharmaceutical drug development; previous experience in Regulatory Affairs highly desirable.

Education: 

• Bachelor's degree in a scientific discipline in preferred. 

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publically traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Specialist/Senior Specialist - QA, reporting to the Associate Director, GMP QA.

Essential duties & responsibilities but not limited to the following:

• Perform batch record review activities for products ensuring products meet specifications and are produced and tested in compliance with approved procedures and applicable regulations

• Compile, organize and file quality records and documentation which include but not limited to executed batch record documentation, manufacturing records, analytical data package, and labeling and packaging records, and associated documentation

• Review analytical data and trend, as required

• Generate key quality performance indicators, collect metrics and perform data trending analysis

• Participate and support internal audits, external audits and regulatory inspections, as required

• Assist in Quality Investigations of GMP activities, Generate Incident Reports, Change Controls and CAPA reports

• Develop and revise Standard Operating Procedures, specifications, validation procedures, work instructions and forms as needed

• Develop and implement methods and procedures for monitoring work activities Special project as required supporting departmental goals

• Perform other duties as assigned

Requirements:.

• Ability to work in a fast-paced environment, willing and eager to work in a hands-on capacity is required

• Must have a minimum of 6 years biopharmaceutical experience with small molecules, preferably oral solid dosage

• The ability to collaborate successfully and build relationships with internal teams, suppliers and agencies is required

• Must have strong computer skills, Microsoft office programs (Word, Excel, PowerPoint, Outlook, etc

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

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publically traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of VP Regulatory Affairs, QA & Project Management.

The Vice-President of Regulatory Affairs (RA), Quality Assurance (QA) & Project Management (PM) will report to the Chief Medical Officer (CMO).  The person in this role will oversee a team of dedicated professionals who are responsible for formulating and implementing the Company’s regulatory strategies, assuring quality throughout the organization, and providing effective project management to support the Company’s business objectives today and in the future. The scope covers global non-clinical development, clinical development, and pharmaceutical manufacturing operations.  The person in this role will be an integral leadership team member in setting the strategy for the development of our products throughout the product lifecycle (pre- and post-approval), will be responsible for communicating risks and outcome of regulatory and quality strategies to the Company’s Executive Committee, and will provide guidance and training in areas of regulatory and quality to other functional groups. 

Duties & Responsibilities but not limited to the following:

• Provide guidance and dynamic leadership for an experienced team of professional regulatory, quality and project management staff. Grow and develop the individual teams to ensure optimal performance today and in the future.

• Provide strategic and technical advice to the Executive Committee and communicate corporate strategic objectives to the regulatory, quality and project management team members and ensure appropriate strategic and tactical plans are in place to meet these objectives. 

• Ensure all regulatory documents are efficiently prepared and submitted in compliance with US and international requirements as indicated.  Work effectively with our Alliance Partners as necessary to achieve this objective.

• Ensure all meetings with regulatory authorities are conducted optimally and that the outcomes are effectively communicated to the Executive Committee.

• Monitor changes in regulations, legislation, guidance documents and policies to determine impact on the company. 

• Establish/maintain highly credible relationships with regulatory health authorities in the US and worldwide, and ensure the company is compliant with US and international requirements.

• Represent the company during Regulatory Authority visits.

• Ensure effective quality oversight of all GXP operations.

• Oversee quality assurance for the existing product in collaboration with our Alliance Partner and oversee quality assurance and regulatory issues for new product development.  Work effectively with Pharmaceutical Operations to ensure that all drug products manufactured, processed, packaged, and distributed by the Company, including any produced by a third party, meet all safety and quality standards that are represented and/or required.

• Work closely with the Chief Compliance Officer to ensure the Company is appropriately trained and is in compliance with US and international regulations as appropriate.  The person in this role is, along with the Chief Compliance Officer, responsible for the oversight of the process for approving marketing and promotional materials.

• Ensure all corrective actions and regulatory commitments are completed in a timely fashion.

• Ensure there is an effective employee training program.

• Ensure effective auditing and corrective action programs are in place to reinforce compliance with the Company’s SOPs.

• Participate in corporate business development initiatives.

• Establish expectations and best practices for project management at the Company in collaboration with other business leaders.  Partner with other corporate leaders to ensure that the Company’s strategic objectives and milestones and the overall project plans are clear and are communicated clearly across the organization to facilitate cross-functional teamwork. 

• Ensure adequate team meetings and infrastructure exists to ensure teams are high-functioning and are working in an effective cross-functional way without silos or politics.

• Responsible for the overall budget and resources for the Regulatory, Quality, and Project Management departments.

Requirements:

• 20+ years in drug development in the biotech/pharmaceutical industry, including significant experience in regulatory and quality affairs. 

• 8+ years demonstrated management experience leading a mid-size department and developing teams effectively.

• Demonstrated strategic development capabilities related to new drug development as well as in international life-cycle product development support. Strong experience and deep knowledge in drug manufacturing, quality assurance and GXP compliance and the associated laws/regulations.

• Extensive experience in the drug development and regulatory approval process ranging from IND’s through NDAs.

• A self-starter with the ability to work and to achieve goals with minimum direction. Must be proactive in identifying issues and recommending solutions.

• International/global experience.

• Excellent oral and written communication skills.

Qualifications:

• Builds strong relationships with internal and external collaborators

• Able to travel locally, nationally, and internationally throughout the year

• Strong management skills as well as excellent communication and interpersonal skills.

Education:

• Advanced scientific degree highly desirable.

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 Documentation Specialist/Senior, GMP.

Essential duties & responsibilities but not limited to the following:

• File final hard-copy GMP documents accurately and in a timely manner

• Upload final GMP documents and enter metadata in electronic document management system (EDMS) accurately and in a timely manner

• Ensure electronic and hard copy files are consistent

• Troubleshoot document inconsistencies and communicate with Pharmaceutical Operations and/or GMP Quality staff to ensure resolution

• Assist with batch data trending and reporting

• Cross-train Document Control staff on GMP Document filing system

• Prepare and process study documentation for off-site storage

• Participate in Pharmaceutical Operations and GMP Quality team meetings

• Provide support during internal audits and inspections

• Conduct work activities in compliance with GxPs and Medivation SOPs and Policies

Requirements:

• 3-7 years in a regulated industry

• 3 years of experience in documentation, manufacturing, Quality Control or GMP Quality Assurance in a regulated industry

Education:

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

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

Essential duties & responsibilties but not limited to the following:

• Upload GMP-mandated documents such as product specifications and batch records in SharePoint and file hard copies in Quality.

• Upload Preclinical study reports and enter metadata within SharePoint and file hard-copy final reports in Quality.

• Assign Preclinical study numbers

• Ensure electronic records are accurate and filed within EDMS correctly

• Assist with Preclinical data trending and reporting

• Track incomplete reports within EDMS and follow-up

• Maintain GLP study library

• Provide support for the Quality System during internal audits and inspections

• Follow GxPs and Medivation SOPs and policies

• Other tasks as assigned such as archival of Quality Management files including training records, consultant files, and vendor qualification / audit files.

Requirements:

• Knowledge of GxP concepts and guidelines. 

• Strong communication and organizational skills

• Attention to detail

• 2-3 years pharmaceutical experience in documentation, quality control or quality assurance

Education 

• Bachelor’s degree in a scientific field 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

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

The Manager/Senior Manager of Market Planning will lead patient, nurse and health systems-related market research efforts for Medivation’s first marketed product. This position reports to the Director of Market Strategy and Planning. This position offers the opportunity to join a team early in the evolution of product life cycle with a fully accrued Phase 3 study for the next indication ongoing. You will be a key contributor to the team in leading primary and secondary research activities for key stakeholder segments.

This role demands strong strategic, analytical and communication skills and we are looking for an individual with a strong track record of success in these areas. 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 & Responsibilities but not limited to the following:

• Support commercial decision-making and strategy development for Medivation products by delivering actionable insights about key stakeholders and the marketplace

• Identify key biotech and pharma industry trends in patient and nurse marketing efforts

• Gain strong understanding of product access issues, particularly with part D drugs, identify opportunities to improve services to payers and physicians and enhance access for patients

• Develop plan for monitoring market landscape, design primary and secondary market research studies, select and hire research vendors and develop and present recommendations

• Develop and defend competitive timeline assumptions, which will be utilized in strategy development and forecasting efforts

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

• Collaborate with co-promote partners and gain consensus regarding market research plans whenever possible

• Manage projects within set budget guidelines

• Present findings and recommendations to senior team members

Requirements:

• Strong presentation, market research and forecasting skills

• Ability to professionally communicate and cultivate strong working relationships

• Minimum 8 years of strategic consulting or related biotech or pharmaceutical industry experience; background in market research and forecasting; preference for individuals with oncology experience; launch experience a plus

• Business Travel is required

Education

• Bachelor’s degree, MBA preferred

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

The Senior Manager of Market Planning (HS) will lead forecasting and physician-focused market research efforts for Medivation’s first marketed product. This position reports to the Director of Market Strategy and Planning. This position offers the opportunity to join a team early in the evolution of product life cycle with a fully accrued Phase 3 study for the next indication ongoing. You will be a key contributor to the team in leading primary and secondary research activities for key physician segments as well as the development and management of forecasts for multiple product indications

This role demands strong strategic, analytical and communication skills and we are looking for an individual with a strong track record of success in these areas. 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 & Responsibilities but not limited to the following:

• Support commercial decision-making and strategy development for Medivation products by delivering actionable insights about key stakeholders and the marketplace

• Identify key biotech and pharma industry trends and determine potential impact on the business and proactively make recommendations to teams regarding elements of clinical trial design, regulatory strategy or commercial execution

• Develop plan for monitoring market landscape, design primary and secondary market research studies, select and hire research vendors and develop and present recommendations to management

• Build and manage product-level forecasts, using market research findings, competitive timeline and threat assessments to determine revenue goals for approved products 

• Develop and defend competitive timeline assumptions, which will be utilized in strategy development and forecasting efforts

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

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

• Manage projects within set budget guidelines

• Present findings and recommendations to senior team members

• Strong presentation, market research and forecasting skills

• Ability to professionally communicate and cultivate strong working relationships

Requirements:

• 3-5 years of strategic consulting or related biotech or pharmaceutical industry experience;

• Background in market research and forecasting;

• Oncology experience preferred

• Launch experience a plus

• Business Travel Required

Education

• Bachelor’s degree in science, MBA preferred

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publically traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Associate Director/Director New Product Planning, reporting to the Vice President, Marketing. 

The Associate Director/Director of New Product Planning will be responsible for strategic planning for new tumor indications for XTANDI, Medivation’s first marketed product and for compounds in the pipeline.

Essential duties & responsibilities but not limited to the following:

• Lead the Joint Lifecycle Management team for the XTANDI collaboration in conjunction with our partner colleagues and providing recommendations for additional development of XTANDI in any indication beyond prostate cancer. 

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

• Work with the Director of Market Analysis & Planning to coordinate any market research needed to support commercial assessments. 

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

• 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.

Requirements

• 7-10 years experience of drug development/life-cycle management

• A successful track record with brand management, new product planning, and/or business development

• Documented experience in overseeing lifecycle management and market development/ expansion activities

• Provide regular executive management updates of progress

• Ability to make sound recommendations based on appropriate market assessments

• Responsible for utilizing primary and secondary market research to build market assessments

• Be known as a thoughtful, collaborative partner with Astellas on XTANDI lifecycle management.  Anticipate and head off problems caused by inefficient communications.  Alert stakeholders internally to any potential issues or roadblocks that may jeopardize success of program

• Coordinate closely with brand team on XTANDI lifecycle planning

• 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.

• 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

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

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

Education:

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