Posted in General Business 30+ days ago.
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Location: Alameda, California
The Senior Medical Affairs Director provides medical oversight for the company's RAMP (Review of Advertising, Marketing, and Promotions) and MRC (Medical Review Committee) processes, leads the RCC 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
•Strategically lead MRC meetings to ensure that all scientific exchanges concerning Exelixis' pipeline and marketed products, and disease states of interest are truthful, non-misleading, balanced, objective, non-promotional in nature and intent, and in compliance with state and federal laws.
•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 RCC Strategic Meetings and deliver training presentations to MSLs and Sales Force/Market 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, RAMP Leadership Meetings and Access teams.
Position Requirements: SUPERVISORY RESPONSIBILITIES:
• Co-Lead disease-specific cross-functional team within Medical Affairs
• No direct reports at this time
• 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
• Typically requires a minimum of fifteen 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 and/or academic experience.
• Experience in the area of Medical Affairs is favorable, but not required
• Experience working with NCI and Cooperative Groups is a plus.
• 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 subordinates or cross-functional teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Applies strong analytical and business communication skills.
• 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.
• Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.
* Telecommute available upon manager discretion.
* Ability to travel domestically and internationally estimated at 25-35%
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.