Patient Safety Epidemiology Associate Director
Vertex Pharmaceuticals · Boston, MA
SafetyFull-time$163k–$245kCompany career page
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Role summary
Associate Director leading safety and regulatory epidemiology initiatives across Vertex's product portfolio and disease areas. Responsible for post-marketing study strategy, study design and execution, regulatory submissions, and cross-functional collaboration on benefit-risk assessments and signal detection.
What they're looking for
- PhD in epidemiology
- 5+ years pharmaceutical, biotech, CRO, or academic epidemiology experience
- Specialized knowledge of pharmacoepidemiologic methods and regulations
- Expertise in observational study design and clinical practice research
- Strong written and verbal communication for scientific audiences
- Project management and independent decision-making abilities
- Ability to build collaborative relationships in matrix environments
What you'll be doing
- Drive company safety risk management, signal detection, and post-marketing regulatory research strategies
- Lead design, feasibility assessment, and implementation of regulatory post-marketing epidemiologic studies
- Develop epidemiology sections for regulatory documents including RMPs, REMS, NDAs, and PSURs
- Conduct systematic literature reviews and signal detection analyses using safety databases
- Oversee publication strategy through conference presentations and peer-reviewed manuscripts
Privacy & handoff
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