Associate Vice President, Therapeutic Area Head (TAH)
Key Responsibilities
- Provide strategic leadership and oversight for clinical safety assessment and risk management across assigned therapeutic area(s).
- Direct/oversee Safety Physicians and Medical Associates for safety surveillance, signal detection, benefit-risk assessment, and risk mitigation.
- Guide development and implementation of risk management strategies and safety communication plans.
- Lead assessment of emerging safety signals; take appropriate actions; serve as Physician Management Reviewer for post-approval safety signal evaluations.
- Serve on safety governance/review committees; represent company in regulatory interactions; maintain relationships with global health authorities.
- Maintain oversight of safety issues and benefit-risk assessments; improve global pharmacovigilance systems, policies, quality standards, and SOPs; support inspection readiness.
- Partner cross-functionally (Clinical Development, Regulatory Affairs, Biostatistics, Epidemiology, etc.) to ensure integrated safety strategies and informed decisions.
- Lead, develop, and mentor Safety Physicians; manage resources (budget/expenses) and drive talent development/succession planning.
Education Requirement
- M.D. or equivalent medical degree (Board Certification preferred).
Required Experience/Skills
- 3+ years clinical experience post-training; 5+ years Clinical Safety/Pharmacovigilance (or related); 9+ years pharma/healthcare experience; people management experience.
- Demonstrated expertise in pharmacovigilance, clinical safety assessment, benefit-risk evaluation; strong global regulations knowledge; strategic influence; executive communication.
Preferred
- Safety strategy leadership across multiple therapeutic areas/global portfolios (Oncology preferred); regulatory interaction success; global PV governance leadership.