Exec Medical Director, Pharmacovigilance Risk Management (PVRM)
Exelixis
June 25, 2026
Remote friendly (Alameda, CA)
United States
Operations
SUMMARY/JOB PURPOSE
- Develop and execute global product safety strategy for complex clinical development programs and post-marketing pharmacovigilance activities. Lead and mentor safety team members; collaborate cross-functionally to support corporate development strategy.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Lead and develop safety strategy for oncology products in clinical development or with marketing authorization.
- Create safety data analysis strategies; interpret safety analysis data.
- Define strategy for key safety deliverables (e.g., safety signals, aggregate reports, risk management planning, safety data pooling, regulatory filing and clinical development documents).
- Lead cross-functional Benefit Risk Team; escalate important safety updates to Benefit Risk Executive Committee.
- Lead development of core safety documents; conduct proactive safety data reviews.
- Oversee safety data evaluations/summaries in global periodic safety aggregate reports.
- Present safety data and provide safety expertise in key meetings (e.g., Health Authorities, DSMBs, investigators).
- Develop risk management strategies and monitoring plans; co-lead benefit-risk assessments.
SUPERVISORY RESPONSIBILITIES
- Supervise direct reports; matrix leadership and cross-functional interactions.
QUALIFICATIONS
- M.D. with minimum 10 years post-residency, or equivalent education/experience.
- 3+ years clinical experience post-residency.
- At least 10 years pharmacovigilance or relevant industry experience; oncology PV is a plus.
- Board certification (if US) preferred; prior project/team leadership preferred.
- Strong knowledge of US/EU pharmacovigilance regulatory requirements.
KNOWLEDGE/SKILLS (selected)
- Advanced analysis/problem-solving; strong planning/communication; ability to mentor and develop staff.
BENEFITS (as stated)
- 401(k) with company contributions; medical/dental/vision; life/disability; flexible spending; discretionary annual bonus; stock purchase; long-term incentives; paid vacation/holidays; sick days.
- Develop and execute global product safety strategy for complex clinical development programs and post-marketing pharmacovigilance activities. Lead and mentor safety team members; collaborate cross-functionally to support corporate development strategy.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Lead and develop safety strategy for oncology products in clinical development or with marketing authorization.
- Create safety data analysis strategies; interpret safety analysis data.
- Define strategy for key safety deliverables (e.g., safety signals, aggregate reports, risk management planning, safety data pooling, regulatory filing and clinical development documents).
- Lead cross-functional Benefit Risk Team; escalate important safety updates to Benefit Risk Executive Committee.
- Lead development of core safety documents; conduct proactive safety data reviews.
- Oversee safety data evaluations/summaries in global periodic safety aggregate reports.
- Present safety data and provide safety expertise in key meetings (e.g., Health Authorities, DSMBs, investigators).
- Develop risk management strategies and monitoring plans; co-lead benefit-risk assessments.
SUPERVISORY RESPONSIBILITIES
- Supervise direct reports; matrix leadership and cross-functional interactions.
QUALIFICATIONS
- M.D. with minimum 10 years post-residency, or equivalent education/experience.
- 3+ years clinical experience post-residency.
- At least 10 years pharmacovigilance or relevant industry experience; oncology PV is a plus.
- Board certification (if US) preferred; prior project/team leadership preferred.
- Strong knowledge of US/EU pharmacovigilance regulatory requirements.
KNOWLEDGE/SKILLS (selected)
- Advanced analysis/problem-solving; strong planning/communication; ability to mentor and develop staff.
BENEFITS (as stated)
- 401(k) with company contributions; medical/dental/vision; life/disability; flexible spending; discretionary annual bonus; stock purchase; long-term incentives; paid vacation/holidays; sick days.