Patient Safety Epidemiology Associate Director

Role: Lead safety and regulatory epidemiology activities for Vertex products across multiple therapeutic areas and lifecycle stages. Responsibilities: oversee post-marketing regulatory studies, conduct epidemiologic research, develop study designs, interpret and communicate findings, contribute to regulatory filings (e.g., RMPs, NDA, PSURs), lead systematic literature reviews, and support signal detection efforts. Collaborate cross-functionally with product teams, safety, and regulatory groups; may supervise junior staff or contractors. Requirements: PhD in epidemiology; 5+ years in pharma, biotech, CRO, or academia with expertise in pharmacoepidemiology, pharmacovigilance regulations, observational study design, and scientific communication. HighValue: expertise in pharmacoepidemiology, post-marketing safety, regulatory strategy, and epidemiologic study development; experience with pharmacovigilance guidelines, signal detection, and scientific publications. WorkSetup: remote-eligible with options for hybrid or onsite, no specific travel indicated.