Director, Clinical Safety Scientist
Job Summary
Risk Management (Signal identification, evaluation, mitigation): Is a key participant in developing and implementing the risk management strategy for assigned products/ TAs; Independently integrates and analyzes safety data from multiple sources to deliver comprehensive conclusions; Independently identifies gaps in safety surveillance plans/RMPs and escalates appropriately.
Safety Communication: Develops strategy for communicating safety information internally and externally in collaboration with product safety lead. Leads the development of safety communication documents and aggregate safety reports.
Project Management: Serves as PM for SMTs devoted to larger Phase 3/4 products and ensures adherence to project timeline.
People Management and Mentoring: Coaches, mentors, and influences junior scientists and team members.
Qualifications
Education Qualifications
- Bachelor's Degree required or PhD preferred or PharmD preferred
Experience Qualifications
- 7 or More Years of experience with an advanced degree required
- 10 or More Years of experience with a bachelor’s degree preferred
- Experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology required
- Possesses strong medical and drug development knowledge required
- Experience in summarizing and presenting safety data required
- Strong communication skills required
- Experience in project management and working in a matrix environment required
- People management experience required
Travel Requirements
- Ability to travel up to 5% of the time. Travel to other CSPV sites or medical conferences as needed
Pay
USD$201,840.00 - USD$302,760.00