Senior Medical Affairs Director (Prostate Cancer) at Exelixis in Alameda, CA

Job Description

The Senior Medical Affair Director - Prostate provides medical oversight for the company’s RAMP (Review of Advertising, Marketing, and Promotions), leads the Prostate Cancer Strategy team with the Executive Medical Director, provides input in the protocol review process for ISTs and CTEP trials, participates in the HEOR project discussions, and ensures strategic cross-functional alignment to achieve the medical mission of supporting safe and appropriate use of our drugs.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Review and approve RAMP materials to ensure all scientific information and promotional claims are medically and scientifically accurate and supported by scientifically appropriate and statistically sound evidence.

- Verify the accuracy of medical and scientific data on RAMP Materials.

- Analyze and advise upon the accuracy and reasonableness of medical practice information in RAMP materials.

- Verify that all promotional claims, including statements about efficacy and safety, are medically and scientifically accurate and true. Ensure that these promotional claims are also supported by scientifically appropriate and statistically sound evidence.

- Provide specific review comments in accordance with the RAMP SOP [REG028].

- Represent the department as an attendee in RAMP Meetings and RAMP Leadership Meetings when requested.

• Participate in MRC (Medical Review Committee) meetings where Prostate Cancer materials are discussed.

• Review Scientific Exchange Materials at MRC to ensure appropriate use, interpretation, and accuracy of the scientific and medical content in accordance with the MRC SOP [MED006-00].

- Evaluate the accuracy of all scientific and medical content used in the Scientific Exchange Materials

- Evaluate the accuracy and reasonableness of medical practice information in all Scientific Exchange Materials.

- Evaluate appropriate interpretation and use of scientific and medical information.

- Consider whether statements are supported by an appropriate level of clinical and/or scientific evidence based on published and non-published data.

- Consider whether efficacy and safety statements are supported by an appropriate level of clinical and/or scientific evidence.

- Evaluate whether language used in Scientific Exchange Materials is appropriate for the intended audience.

- Monitor changes in the scientific, medical and clinical environment that may impact any proposed or approved Scientific Exchange Material and inform MRC and material owner as appropriate.

• Review the IST and CTEP trial protocol after Concept acceptance in alignment with the IST SOP [MED009] as well as the HEOR protocols, and provide comments as necessary.

• In collaboration with the Executive Medical Director, manage the planning and implementation of the Medical Affairs Prostate Cancer Strategic Meetings and deliver training presentations to MSLs and Sales Force/Market Access teams.

EDUCATION/EXPERIENCE/SKILLS:

Education:

• Accredited doctorate degree in a basic-science or life-science discipline (Pharm.D., Ph.D., D.Sc., D.N.P., or M.D./D.O.) or Master’s level oncology PA or NP with active commitment towards completion of doctorate degree preferred

Experience:

• Typically requires a minimum of fifth teen years of related experience and/or combination of experience and education/training.

• 5+ years of experience in the biotech or pharmaceutical industry in the area of oncology.

• Experience in the area of Medical Affairs is favorable, but not required

• Experience working with NCI and Cooperative Groups is a plus.

Knowledge/Skills/Abilities:

• Has experience in relevant industry/profession.

• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.

• Develops technical and/or business solutions to complex problems.

• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.

• Guides the successful completion of major programs, projects and/or functions.

• Leads or manages the work of others by providing guidance to cross-functional teams based on organizational goals and company policy, with responsibility for results, including methods.

• Applies strong analytical and business communication skills.

JOB COMPLEXITY:

• Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company.

• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.