Exec Medical Director, Pharmacovigilance Risk Management (PVRM)

SUMMARY / JOB PURPOSE

The Executive Medical Director, PVRM is responsible for the development and execution of the global product safety strategy for complex clinical development program(s) as well as post‑marketing pharmacovigilance activities for Exelixis products. This role leads and mentors team members to proactively and successfully plan and manage key safety surveillance activities, safety analyses, risk management and safety document deliverables. This role also engages and collaborates cross‑functionally to execute on the corporate development strategy.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Lead and develop the safety strategy for complex clinical development programs for oncology products in development or products with a marketing authorization.
• Create appropriate safety data analysis strategies across clinical studies for a product.
• Perform appropriate data interpretation on the performed safety analyses for a product.
• Set a clear strategy for key safety deliverables for the product (e.g., safety signals, aggregate reports, risk management planning, safety data pooling, regulatory filing documents, clinical development documents).
• Lead the cross‑functional Benefit‑Risk Team for the assigned product and escape important safety updates to the Benefit‑Risk Executive Committee in a timely fashion.
• Lead the development of core safety documents, which characterize the safety profile of the product appropriately.
• Lead proactive safety data reviews and anticipate safety concerns for the assigned product.
• Oversee the development of safety data evaluations and summaries in the global periodic safety aggregate reports for the product.
• Present safety data and provide safety expertise on the product during key meetings (e.g., with Health Authorities, Data Safety Monitoring Boards and Investigators).
• Develop risk management strategies and monitoring plans for risk management effectiveness for the product.
• Co‑lead the benefit‑risk assessment for the product with other functions.

SUPERVISORY RESPONSIBILITIES

Has supervisory responsibilities over direct reports and involves significant cross‑functional and cross‑departmental interactions with clinical development, biometrics, medical affairs and regulatory affairs.

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS

• M.D. degree and a minimum of 10 years of post‑residency experience; or equivalent combination of education and experience.
• 3+ years of clinical experience post‑residency; board certification (if US) preferred.
• At least 10 years of experience in pharmacovigilance or other relevant experience in a pharmaceutical/biotechnology company.
• Significant clinical experience may compensate for shorter experience in pharmaceutical/biotech company.
• Pharmacovigilance experience in oncology is a plus.
• Prior project and team leadership/management experience is preferred.
• Extensive knowledge of biotechnology/pharmaceutical sector drivers, US and international pharmacovigilance regulations, and their practical application throughout the product lifecycle.
• Advanced skills in gathering, analyzing and applying key information to solve complex problems; strong organizational and planning capabilities; high standards of verbal and written communication; strong interpersonal skills; ability to develop and maintain knowledge of cross‑functional products, tools and data sources.
• Mentorship of junior team members; contribution to performance reviews and professional development plans.

JOB COMPLEXITY

Capable of strategically and proactively assessing workload, trends, tasks, and priorities for cross‑functional activity; plans and executes multiple projects or activities, considering alternative methods and contingency plans to avoid potential issues and promote efficiency; designs and implements solutions to address cross‑functional challenges, considering the broader impact.

WORKING CONDITIONS

The office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

EQUITY OPPORTUNITIES & BENEFITS

Exelixis offers a comprehensive employee benefits package, including a 401(k) plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, flexible spending accounts, discretionary annual bonus program, stock purchase options, long‑term incentives, vacation days, paid holidays, and sick days.

EQUAL OPPORTUNITY EMPLOYER

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.

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