Director Pharmacoepidemiology

Temp - Director Pharmacoepidemiology

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The Pharmacoepidemiologist with qualifications commensurate with the Director level will be accountable for development and implementation of pharmacoepidemiology strategy in the designated therapeutic area (TA), 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. The Pharmacoepidemiologist will 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.

Under supervision of the Pharmacoepidemiology Therapeutic Area (TA) lead for General Medicines:

• Responsible for pharmacoepidemiology strategy generation of real-world evidence (RWE), and 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 with external partners), Regeneron Safety Oversight Committee, and Independent Data Monitoring Committees
• Proactively lead non-compound specific pharmacoepidemiology activities (ex. literature review and database queries in support of regulatory filling)
• 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 GPS and across Regeneron, as appropriate
• Manage 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

This role requires:

• A results-oriented, collaborative style.
• Ability to build consensus with leaders and colleagues to gain support for initiatives.
• Proven track record of developing and maintaining relationships with partners at all levels of the organization.
• Previous experience in and deep understanding of the drug development process.
• Ability to manage and prioritize multiple tasks and projects with a sense of urgency and to navigate within a matrix organization.
• Experienced in planning and execution; thinks strategically and executes tactically in order to deliver positive results for the business.
• Strong business and financial management acumen.
• Demonstrated resiliency; able and willing to explore different paths to achieve an outcome. Consistently demonstrates good judgment. Takes initiative to bring forward new ideas to improve processes and programs.
• Outstanding verbal and written communication and presentation skills; ability to communicate accurately and concisely

Education: Minimum of a Bachelors degree and 8+ years of relevant industry related experience in Biotech/Pharma

About Us

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has