Exec Medical Director, Pharmacovigilance Risk Management (PVRM)
Exelixis
2 days ago
Remote friendly (Alameda, CA)
United States
Operations
Executive Medical Director (PVRM)
Responsibilities:
- Lead and develop global product safety strategy for complex clinical development programs and post-marketing pharmacovigilance activities for oncology products.
- Create safety data analysis strategies across clinical studies; interpret safety analysis results.
- Define safety deliverables strategy (e.g., safety signals, aggregate reports, risk management planning, safety data pooling, regulatory filings, clinical development documents).
- Lead cross-functional Benefit Risk Team; escalate key safety updates to the Benefit Risk Executive Committee.
- Lead development of core safety documents; conduct proactive safety data reviews and anticipate safety concerns.
- Oversee safety evaluations and summaries in global periodic safety aggregate reports.
- Present safety data/expertise in key meetings (Health Authorities, DSMBs, Investigators).
- Develop risk management strategies and monitoring plans for effectiveness.
- Co-lead benefit-risk assessments.
Supervisory/Collaboration:
- Supervise direct reports; significant interactions with clinical development, biometrics, medical affairs, and regulatory affairs.
Qualifications:
- M.D. with 10+ years post-residency experience, or equivalent education/experience.
- 3+ years clinical experience post-residency.
- Board Certification (US) preferred.
- 10+ years pharmacovigilance (or relevant) experience in pharma/biotech; oncology PV a plus.
- Prior project/team leadership preferred.
- Strong knowledge of US/EU pharmacovigilance regulatory requirements.
Skills:
- Advanced analytical problem-solving; strong organizational/planning skills; high verbal/written communication; strong interpersonal skills; ability to mentor and train teams.
Benefits (as stated):
- 401(k), medical/dental/vision, life/disability, flexible spending; discretionary annual bonus; stock purchase and long-term incentives; paid time off (vacation/holidays) and sick days.
Responsibilities:
- Lead and develop global product safety strategy for complex clinical development programs and post-marketing pharmacovigilance activities for oncology products.
- Create safety data analysis strategies across clinical studies; interpret safety analysis results.
- Define safety deliverables strategy (e.g., safety signals, aggregate reports, risk management planning, safety data pooling, regulatory filings, clinical development documents).
- Lead cross-functional Benefit Risk Team; escalate key safety updates to the Benefit Risk Executive Committee.
- Lead development of core safety documents; conduct proactive safety data reviews and anticipate safety concerns.
- Oversee safety evaluations and summaries in global periodic safety aggregate reports.
- Present safety data/expertise in key meetings (Health Authorities, DSMBs, Investigators).
- Develop risk management strategies and monitoring plans for effectiveness.
- Co-lead benefit-risk assessments.
Supervisory/Collaboration:
- Supervise direct reports; significant interactions with clinical development, biometrics, medical affairs, and regulatory affairs.
Qualifications:
- M.D. with 10+ years post-residency experience, or equivalent education/experience.
- 3+ years clinical experience post-residency.
- Board Certification (US) preferred.
- 10+ years pharmacovigilance (or relevant) experience in pharma/biotech; oncology PV a plus.
- Prior project/team leadership preferred.
- Strong knowledge of US/EU pharmacovigilance regulatory requirements.
Skills:
- Advanced analytical problem-solving; strong organizational/planning skills; high verbal/written communication; strong interpersonal skills; ability to mentor and train teams.
Benefits (as stated):
- 401(k), medical/dental/vision, life/disability, flexible spending; discretionary annual bonus; stock purchase and long-term incentives; paid time off (vacation/holidays) and sick days.