Associate Director Epidemiology
Vertex Pharmaceuticals Inc (US)

Boston, Massachusetts

Posted in Retail
about 1 month ago

This job has expired.

Job Info

Associate Director Epidemiology leads safety and regulatory epidemiology activities for Vertex products across multiple therapeutic areas and throughout all phases of lifecycle. Associate Director is a major contributor to the company safety risk management, signal detection, benefit/risk assessments and post-marketing commitment research strategies. This incudes all aspects of execution of post-marketing regulatory commitment studies (comprehensive epidemiologic feasibility assessments, epidemiologic study design, study implementation, interpretation of study findings and their communication to internal and external audiences).

Associate Director is a subject matter expert in pharmacoepidemiologic methods, pharmacovigilance regulations, and specific therapeutic areas, including Associate Director supports the company global observation research efforts in collaboration with other line functions (Regulatory Affairs, Clinical Development, Biostatistics, Real World Evidence, Global Medical Affairs, Health Economics and Outcomes Research and Clinical Operations).


- Effectively communicates safety and regulatory epidemiologic strategy to product teams

- Leads the development of epidemiology sections for Risk Management Plans (EU RMP, REMS, etc.) and other regulatory filings (NDA, PSUR, etc.) for products throughout lifecycle

- Leads systematic and targeted epidemiologic literature reviews, and epidemiologic analyses to estimate the background rates of events to support safety evaluation

- Supports signal detection analyses of safety reporting system databases (FAERS, Vigibase) or other sources (e.g. Sentinel)

- Leads all stages of the design and implementation of regulatory post-marketing studies: from feasibility assessments, development of study designs and protocols, and execution of studies, to communication and dissemination of their results to internal and external (e.g., Regulatory Agencies, scientific communities) stakeholders

- Contributes to company publications strategy via development of conference

abstracts, presentations, peer-reviewed manuscripts based on the findings of epidemiological studies

- Leads study execution teams for post-marketing regulatory studies

- Actively participates at strategic meetings including Disease Safety Teams

- Collaborates cross-functionally to support company strategy for observational research, integrating innovative study methodologies

- May supervise interns and / or contractors


- PhD in epidemiology is required, pharmacoepidemiology training is preferred

- 5+ years' experience in pharmaceutical/biotechnology industry (preferred), CRO, or academic setting

- Solid knowledge of study design methodology in general medicine and clinical practice, evidenced by experience in designing/implementation of epidemiology studies

- Strong knowledge in pharmacovigilance guidelines and regulations is a plus

- Excellent verbal and written communication skills, including experience with scientific presentations and peer-reviewed publications, to translate epidemiologic research methods and results to diverse audiences

- Excellent independent decision-making skills

- Strong project management skills

This job has expired.

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