ProClinical is currently supporting a leading Pharmaceutical client who are seeing an experienced Director, Epidemiology to join their rapidly growing team, based in Cambridge, MA. In this newly created role, you will be responsible for building the observational research capability for the business, design and execution of epidemiology strategy across programs and throughout all phases of product lifecycle.
- Provide epidemiologic strategy to cross functional product teams
- Lead epidemiologic study design and execution in close partnership with Clinical Safety and Pharmacovigilance, Clinical Development and Medical Affairs as well as with external vendors.
- Provide epidemiologic literature search as well as support analyses of epidemiologic data sets to aid risk management planning, safety signal evaluations, ad hoc queries, aggregate reports and epidemiologic studies as well as supporting Clinical Development queries regarding focus disease states.
- Provides epidemiologic input into strategic documents, including regulatory filings (NDA, PSUR, etc.)
- Provides input into Risk Management Plans (DRMP, RMP, REMS, etc.) for products throughout lifecycle
Skills and Requirements:
- PhD in epidemiology required
- Formal training in pharmacoepidemiology preferred
- At least 5 years’ experience in pharmaceutical/biotechnology industry, CRO, or drug development company in clinical, regulatory or pharmacovigilance functions
- Strong knowledge in pharmacovigilance guidelines and regulations; knowledge of international PV regulations is a plus
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Anna Graham on +1 646 542 0152 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.