About this role
Job title: Director, Clinical Safety Scientist
About the Role The Director, Clinical Safety Scientist will handle aspects of signal identification, evaluation, and risk mitigation across therapeutic areas in collaboration with product safety leads. This role proactively creates communication plans for important safety topics and identified risks, and may serve as primary author for certain safety documents and regulatory submissions. It may project manage larger Phase 3/4 SMTs and supervise junior scientists, working closely with CSPV staff, SMT members and other functions.
What You'll Do
- Lead development and implementation of the risk management strategy for assigned products/therapeutic areas; independently integrates and analyzes safety data from multiple sources to deliver comprehensive conclusions; identify gaps in safety surveillance plans/RMPs and escalate appropriately.
- Develop strategy for communicating safety information internally and externally in collaboration with product safety lead; lead the development of safety communication documents and aggregate safety reports.
- Serve as project manager for SMTs devoted to larger Phase 3/4 products and ensure adherence to project timelines.
- Coach, mentor, and influence junior scientists and team members.
- May manage a team of scientists who support multiple products.
What We're Looking For
- Education: Bachelor's Degree required; PhD or PharmD preferred.
- Experience: 7+ years with an advanced degree or 10+ years with a bachelor’s degree; in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology.
- Strong medical and drug development knowledge; experience in summarizing and presenting safety data.
- Strong communication skills; experience in project management and working in a matrix environment.
- People management experience.
- Travel: Ability to travel up to 5% of the time.
Compensation & Benefits
- Salary range: USD 201,840.00 - USD 302,760.00 per year.
- Equal opportunity/affirmative action employer.
- Benefits: Not specified in posting. Benefits Summary PDF available.