Director, Safety Data Sciences (people manager)

Director-level position overseeing safety data sciences team within a therapeutic area at a pharmaceutical company. Responsible for signal detection, benefit-risk evaluation, and regulatory submissions throughout product lifecycle, with direct management of safety data scientists and strategic collaboration across clinical and statistical functions.

Responsibilities

• Oversee surveillance and regulatory activities for designated therapeutic area; manage full-time safety data scientists and contract personnel
• Lead benefit-risk evaluation and safety risk management in collaboration with therapeutic area heads, physicians, and data sciences teams
• Author and review global aggregate safety reports; develop strategies for routine and ad hoc safety analyses
• Prepare summaries of safety data for Product Safety Team, senior management, and regulatory meetings
• Train new safety scientists and mentor colleagues; identify partnership opportunities to improve organizational efficiencies

Requirements

• Bachelor's degree in health sciences plus 7 years clinical/pharma/safety experience, or Master's/doctorate plus 5 years relevant experience
• Knowledge of drug development, clinical trials, and regulatory requirements for submissions and post-marketing support
• Understanding of drug safety evaluation tools, standards, and approaches
• Experience influencing senior management and functional heads
• People management experience with demonstrated ability to develop and mentor team members
• Strong written and oral communication skills; proficiency in Microsoft Word and Excel
• Ability to work independently, problem-solve, and manage multiple concurrent projects