Senior Director, Medical Safety Assessment Program Lead, Neuroscience

Senior Director leading medical safety assessment for neuroscience compounds at Bristol Myers Squibb. Responsible for overseeing safety strategy, benefit-risk assessment, regulatory submissions, and signal management across development and postmarketing phases.

Responsibilities

• Chair Safety Management Teams and oversee aggregate safety review documents for assigned compounds
• Coordinate Medical Safety Assessment Physicians for signal evaluation and management across data sources
• Lead safety labeling strategy and serve as subject matter expert for regulatory product labeling
• Represent Patient Safety at health authority and data monitoring committee meetings
• Drive process improvement projects and maintain state-of-the-art pharmacovigilance procedures

Requirements

• Medical degree with expertise in pharmacovigilance and safety assessment
• Experience leading safety strategy for pharmaceutical compounds through development and postmarketing
• Knowledge of global regulatory requirements and health authority interactions
• Experience coordinating cross-functional teams and managing multiple safety submissions
• Proficiency in signal evaluation, risk management planning, and benefit-risk assessment
• Experience with clinical trial documents, regulatory filings, and safety labeling