Senior Director, Pharmacoepidemiology

Overview

Regeneron Pharmaceuticals is seeking a Senior Director, Pharmacoepidemiology to join our team!

In this role, a typical day might include:

Reporting to the VP of Global Patient Safety, Pharmacoepidemiology (PEPI), this Senior Director role will be accountable to support the designated pharmacoepidemiology therapeutic area lead, and leading cross-functional project teams and epidemiology activities such as regulatory agency-required epidemiologic studies and generation of epidemiology data to support clinical development and regulatory filings and approval, in accordance with global regulations and Regeneron SOPs and working practices.

Serve as an in-house subject matter expert in epidemiology to other departments. The candidate should be knowledgeable in the latest epidemiologic methods and resources to be able to be responsive within cross-functional teams and to influence decision making where needed.

Reporting to the VP of Pharmacoepidemiology:

• Responsible for supporting the designated pharmacoepidemiology therapeutic area lead and leading the pharmacoepidemiology strategy and oversight of the generation of real-world evidence (RWE). Additionally, responsible for conduct of regulatory agency required epidemiologic studies for post-marketing commitments (e.g., PASS, PAES, PMR, DUS, effectiveness of REMS and RMMs) in support of clinical development, regulatory filings, and post-marketing requirements.
• 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 Global Patient Safety (GPS) Leads, Safety Scientists, Clinical Scientists, Regulatory Affairs and other functions, provide timely epidemiological and risk management strategy and 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 Safety Monitoring Teams (SMT), Clinical Study Teams (including external partners), Regeneron Safety Oversight Committee, and Independent Data Monitoring Committees.
• Proactively lead non-compound specific pharmacoepidemiology activities (e.g. literature review and database queries in support of regulatory filing).
• Actively drive and participate in the development and maintenance of relevant SOPs and Working Instructions.
• Actively drive and participate in process improvement activities and strategic initiatives of GPS and across Regeneron, as appropriate.
• Manage and/or develop direct report(s), contractors, and external vendors, as appropriate.
• Develop and maintain professional relationships and collaborations with external experts and opinion leaders to ensure high quality evidence generation.

• Doctoral degree in epidemiology or a related field, generally with 8+ years of relevant post-doctoral experience with 8+ years of Industry/Regulatory experience preferred.
• Other post-graduate degree in epidemiology or a related field (e.g. MPH, MSc), generally with 10+ years of relevant experience with 8+ years of Industry/Regulatory experience preferred.
• Demonstrated achievements of increasing complexity/responsibility.
• Proven history as a subject matter expert in the field of pharmacoepidemiology, and ability to represent the function both internally and externally
• Up-to-date knowledge of US and international regulatory guidance’s (e.g., pharmacovigilance, RWE, good epidemiology practices) and ability to apply this knowledge to pharmacoepidemiology activities throughout the product life-cycle.
• Experienc…