AVP, Therapeutic Area Head, Clinical Safety and Risk Management

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.

Required/Preferred Skills (high level)

• Clinical safety, pharmacovigilance, benefit-risk assessment, risk management, signal detection, safety governance, regulatory affairs, compliance, stakeholder leadership.

Compensation/Benefits (if applicable)

• Annual bonus/long-term incentive (if applicable).
• Comprehensive benefits including medical/dental/vision, retirement/401(k), paid holidays/vacation, sick/compassionate days.