Head of Benefit-Risk and Pharmacoepidemiology
Sanofi
September 02, 2026
On-site
Cambridge, MA
$293,250 - $423,583.33 USD yearly
Medical Affairs
Main Responsibilities:
- Provide overall Epidemiology and Benefit-Risk (BR) strategies to address safety issues and risk management for all products across all GBUs (Discovery, Development, post-marketing).
- Accountable for Epidemiology safety studies (PASS) to meet regulatory requirements.
- Accountable for Epidemiology risk assessments and structured BR evaluations for internal safety governance (BRAC, PSB, MRP-TC).
- Support the Chief Safety Officer in developing and implementing PSPV Epidemiology and BR strategy and vision.
- Lead and manage the Epi & BR team (capability building, professional development, and Global Pharmacovigilance budget).
- Serve as the company’s leading expert in Epidemiology and Benefit–Risk evaluation.
- Lead external public-private partnerships to foster new methods/tools, shape policy/agenda aligned with scientific and business objectives, and enhance external reputation.
- Advance external reputation via collaborations, presentations, and lectures to regulators/academia as needed.
- Develop and implement strategy/process for rapid access and analysis of real-world data (RWD) for Epi & BR studies.
Qualifications (Preferred/Required):
- Ph.D. (or other doctoral degrees such as PharmD, Sc.D., Dr.P.H) in Biomedical Sciences/Public Health, or M.D. with advanced master’s/doctorate degree in Biomedical Sciences/Public Health.
- 15+ years in Epidemiology, Benefit-Risk Evaluation, Risk Management, signal detection/management, and related patient safety sciences (with Ph.D.); or 12+ years with an M.D.
- Preferably 8+ years in the pharmaceutical industry.
- Leadership experience in external partnerships; proven scientific publication record.
- Travel up to 25% overall.
Knowledge/Skills:
- Leadership and management; stakeholder education; leadership in pharmaceutical scientific activities with regulatory/public health agencies.
- Strong quantitative skills (statistics/biostatistics) and critical analytics.
- Ability to lead industry/public-private working groups; strong teamwork/interpersonal skills.
- Strong knowledge of RWD and regulatory guidelines (ICH, CIOMS, FDA, EU) including post-authorization safety studies, RMP, data privacy, patient registries, and epi study guidelines (e.g., ENCePP).
- Provide overall Epidemiology and Benefit-Risk (BR) strategies to address safety issues and risk management for all products across all GBUs (Discovery, Development, post-marketing).
- Accountable for Epidemiology safety studies (PASS) to meet regulatory requirements.
- Accountable for Epidemiology risk assessments and structured BR evaluations for internal safety governance (BRAC, PSB, MRP-TC).
- Support the Chief Safety Officer in developing and implementing PSPV Epidemiology and BR strategy and vision.
- Lead and manage the Epi & BR team (capability building, professional development, and Global Pharmacovigilance budget).
- Serve as the company’s leading expert in Epidemiology and Benefit–Risk evaluation.
- Lead external public-private partnerships to foster new methods/tools, shape policy/agenda aligned with scientific and business objectives, and enhance external reputation.
- Advance external reputation via collaborations, presentations, and lectures to regulators/academia as needed.
- Develop and implement strategy/process for rapid access and analysis of real-world data (RWD) for Epi & BR studies.
Qualifications (Preferred/Required):
- Ph.D. (or other doctoral degrees such as PharmD, Sc.D., Dr.P.H) in Biomedical Sciences/Public Health, or M.D. with advanced master’s/doctorate degree in Biomedical Sciences/Public Health.
- 15+ years in Epidemiology, Benefit-Risk Evaluation, Risk Management, signal detection/management, and related patient safety sciences (with Ph.D.); or 12+ years with an M.D.
- Preferably 8+ years in the pharmaceutical industry.
- Leadership experience in external partnerships; proven scientific publication record.
- Travel up to 25% overall.
Knowledge/Skills:
- Leadership and management; stakeholder education; leadership in pharmaceutical scientific activities with regulatory/public health agencies.
- Strong quantitative skills (statistics/biostatistics) and critical analytics.
- Ability to lead industry/public-private working groups; strong teamwork/interpersonal skills.
- Strong knowledge of RWD and regulatory guidelines (ICH, CIOMS, FDA, EU) including post-authorization safety studies, RMP, data privacy, patient registries, and epi study guidelines (e.g., ENCePP).