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Executive Director, Epidemiology
| Hours | Full-time, Part-time |
|---|---|
| Location | Cambridge, Massachusetts |
About this job
The Executive Director Epidemiology will provide leadership for all epidemiology activities in the global pharmacovigilance and risk management department in Sarepta. This individual will serve as a member of the Safety Evaluation & Risk Management (SERM) group and supervise epidemiology talent comprising in-house and outsourced resources. The Executive Director Epidemiology will function in a company matrix team environment interacting with several key stakeholder groups including; Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, Manufacturing, Commercial, Research and Legal.
Key Responsibilities:
- Leads/contributes to integration of Epidemiology into the R&D clinical development process & post-marketing safety activities via participation in cross-functional clinical trial, clinical development and global development teams.
- Responsible for design and conduct of pharmacoepidemiology studies: Observational studies with primary safety objectives e.g. post-marketing requirements for observational safety studies to characterize a safety concern.
- Risk Management Plan safety studies (registry, cohort, surveys, case-control or drug utilization studies).
- REMS/RMP Risk Minimization studies (KAB Surveys, Measurement of Effectiveness studies).
- Contributes to product safety evaluation in NDA/BLAs/MAAs.
- Responsible for epidemiology information in Core Risk Management Plans and REMS.
- Leads assessment, interpretation & communication of relevant scientific literature; maintains awareness of internal & external data resources & identifies appropriate studies for addressing questions of interest, independently performs data queries & summarizes epidemiologic information.
- Collaborates with other functional groups (Medical Affairs, Commercial, Regulatory Affairs) in preparing documentation for reimbursement agencies or other external organizations.
- Contributes to signaling and data mining activities utilizing internal and external sources of data.
- Develops methodologies for establishing thresholds for product safety signals.
- Undertakes risk assessment of extrinsic sources of risk (systems) utilizing methodologies such as root cause analysis or FMEA.
- Participates in discussion of product safety issues at the Safety Detection Team and Global Safety Committee.
- Contributes to the company labeling management process and Labeling Committee discussions on product core data sheets and country package inserts.
- Collaborates with Safety Physicians and Safety Scientists in production of periodic ADR safety reports e.g. PADER, PSUR/PBRER.
- Maintains knowledge & skills on evolving epidemiological methods, tools & data sources.
- Leads and grows the Epidemiology group in the Global Pharmacovigilance Department.
- Perform other related duties as needed.
Education and Skills Requirements:
- MSc. or Ph.D. or Sc.D. Epidemiology/Pharmacoepidemiology or MPH with experience in the pharmaceutical industry.
- At least ten years’ experience in epidemiology including a minimum of 5 years’ pharmaceutical industry experience in global pharmacovigilance & risk management.
- Experience contributing to or involvement in NDA, BLA, MAA process including leading design and implementation of natural history studies and registries in the pharmaceutical industry is required.
- Experience leading, and supervising talent is required and experience with rare disease is a plus.
- Key Skills, Abilities and Competencies:
- Ability to use or interpret analysis results from data mining or signaling software tools.
Strategic risk management planning. - Ability to work in a cross-functional team environment.
- Works on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors.
- Ability to use or interpret analysis results from data mining or signaling software tools.
- Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Receives minimal supervision. Expected to solicit input from others in Global Pharmacovigilance, Medical Affairs, Commercial, Regulatory Affairs and Clinical Development and to independently implement existing and new approaches for the design of studies and analysis of safety data.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
Posted 16 Days Ago
Full time
R-00171
About Us
Sarepta Therapeutics, Inc. (NASDAQ: SRPT) is at the forefront of precision genetic medicine, having built a world leading pipeline for the treatment of Duchenne muscular dystrophy (DMD). The Company has expanded its portfolio to include Limb-girdle muscular dystrophy (LGMD) and central nervous system (CNS) disorders across several therapeutic modalities, including RNA, gene therapy and gene editing. If you are interested in an organization that is collegial, entrepreneurial and driven toward success, we invite you to apply today.