Head of Benefit-Risk and Pharmacoepidemiology
Sanofi
September 02, 2026
On-site
Morristown, NJ
$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 across all products/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 decision-making (BRAC, PSB, MRP-TC).
- Support the Chief Safety Officer in developing and implementing overall Epidemiology and BR strategy/vision for PSPV.
- Lead and manage the Epi & BR team: build world-class capability, manage team development, and manage budget under Global Pharmacovigilance.
- Serve as the company’s leading expert in Epidemiology and Benefit-Risk evaluation.
- Lead external public-private partnerships to advance approaches/methods/tools, shape policies/agendas aligned to company objectives, and improve external reputation.
- Advance external reputation via collaborations, presentations, and lectures to regulators/academia.
- Real-World Data: develop and implement strategy/process for rapid access and analysis of real-world data for Epi/BR safety evaluation.
Qualifications (About You):
- Preferred: PhD (or other doctoral degrees such as PharmD, Sc.D, Dr.P.H) in Biomedical Sciences/Public Health or MD with advanced degree in Biomedical Sciences/Public Health.
- Required experience: 15+ years (PhD) and/or 12+ years (MD) in Epidemiology, Benefit-Risk evaluation, Risk Management, signal detection/management; preferably 8+ years in pharma industry.
- Experience leading external partnerships; proven scientific publications.
Knowledge/Skills (required/preferred):
- Leadership and management; problem-solving and initiative.
- Ability to educate stakeholders on pharmacoepidemiology results.
- Experience interacting with regulators/public health agencies; knowledge of post-marketing and clinical development.
- Advanced quantitative skills (statistics/biostatistics/critical analytics).
- Ability to lead industry/public-private working groups.
- Strong understanding of real-world data and regulatory guidance (ICH, CIOMS, FDA, EU), RMP, patient registries, and epi study guidelines (e.g., ENCePP).
- Travel up to 25%.
- Provide overall Epidemiology and Benefit-Risk (BR) strategies to address safety issues and risk management across all products/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 decision-making (BRAC, PSB, MRP-TC).
- Support the Chief Safety Officer in developing and implementing overall Epidemiology and BR strategy/vision for PSPV.
- Lead and manage the Epi & BR team: build world-class capability, manage team development, and manage budget under Global Pharmacovigilance.
- Serve as the company’s leading expert in Epidemiology and Benefit-Risk evaluation.
- Lead external public-private partnerships to advance approaches/methods/tools, shape policies/agendas aligned to company objectives, and improve external reputation.
- Advance external reputation via collaborations, presentations, and lectures to regulators/academia.
- Real-World Data: develop and implement strategy/process for rapid access and analysis of real-world data for Epi/BR safety evaluation.
Qualifications (About You):
- Preferred: PhD (or other doctoral degrees such as PharmD, Sc.D, Dr.P.H) in Biomedical Sciences/Public Health or MD with advanced degree in Biomedical Sciences/Public Health.
- Required experience: 15+ years (PhD) and/or 12+ years (MD) in Epidemiology, Benefit-Risk evaluation, Risk Management, signal detection/management; preferably 8+ years in pharma industry.
- Experience leading external partnerships; proven scientific publications.
Knowledge/Skills (required/preferred):
- Leadership and management; problem-solving and initiative.
- Ability to educate stakeholders on pharmacoepidemiology results.
- Experience interacting with regulators/public health agencies; knowledge of post-marketing and clinical development.
- Advanced quantitative skills (statistics/biostatistics/critical analytics).
- Ability to lead industry/public-private working groups.
- Strong understanding of real-world data and regulatory guidance (ICH, CIOMS, FDA, EU), RMP, patient registries, and epi study guidelines (e.g., ENCePP).
- Travel up to 25%.