The Director will be responsible for leading pharmacoepidemiologic activities and cross-functional project teams to generate epidemiology data in support of clinical development and regulatory filings and approval for the assigned marketed products and/or development compounds and providing consultation as an in-house subject matter expert in epidemiology to other departments.
With general support from Head of Pharmacoepidemiology:
- Responsible for conduct of regulatory-agency required epidemiologic studies such as PASS, PAES, PMR, DUS, effectiveness of REMS and RMMs in support of clinical development, regulatory filings, and postmarketing requirements for the assigned marketed products / development compound(s)
- As a subject matter expert, contribute to other pharmacoepidemiology activities, including but not limited to: (Development) Risk Management Plans; Benefit-Risk analyses; signal management; responses to regulatory agency queries; regulatory filings
- Working closely with Regulatory Affairs, Risk Management Leads and other functions, provide timely epidemiological and risk management support to project and product teams of TAs including design, implementation and data analysis of epidemiological studies, review of study proposal from internal and external sources, and database activities such as exploring external electronic, patient-level database(s) (administrative claims/EMR/surveys/registries etc) to evaluate safety/benefit questions, mortality and morbidities/comorbidities, and other appropriate epidemiologic data in support of clinical development and regulatory filings
- Represent Pharmacoepidemiology on cross-functional teams, including Risk Management Task Force (RMTF), Safety Monitoring Teams (SMT), Clinical Study Teams (including with external partners), Regeneron Safety Oversight Committee, and Independent Data Monitoring Committees as needed
- Provide inputs to IIS studies and other epidemiologic consultation on epidemiologic studies to other departments such as Regeneron Genetic Center
- Participate in the development and maintenance of relevant SOPs and Working Instructions as needed
- Participate in process improvement activities within Regulatory Affairs as needed
- Doctoral degree in epidemiology or a related field, generally with 5+ years of post-doctoral experience, including 3+ years of industry/regulatory experience.
- Other post-graduate degree in epidemiology (ex. MPH, MSc), generally with 8+ years of experience including 5+ years of industry/regulatory experience.
- Excellent communication and interpersonal skills.
- Demonstrated achievements of increasing complexity/ responsibility.
- Up-to-date knowledge of US, EU, and international regulatory and pharmacovigilance requirements and ability to apply this knowledge to activities for clinical trial and post-marketing environments
- Function as a subject matter expert on epidemiology for assigned compounds
- Experience utilizing automated healthcare databases (internal and large external databases) to support pharmacoepidemiologic activities
- Experience working with external vendors
- Doctoral degree in epidemiology or a related field
- MD, plus other post-graduate degree in epidemiology or a related filed (e.g. MPH, MSc)