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. #J-18808-Ljbffr Scorpion Therapeutics