Head of Benefit-Risk and Pharmacoepidemiology

BioSpace; Morristown (NJ); On-site; USD 350,000 - 550,000; Full time

Job summary

Sanofi in Morristown, NJ seeks a visionary Head of Epidemiology and Benefit-Risk (Epi & BR) to lead regulatory data generation, innovate methods, and guide external partnerships across RWE. You will shape risk management strategies for all products and oversee a global team of experts.

Expect up to 25% travel, collaboration with regulators, and responsibility for advancing science while aligning with business objectives within PSPV/BR.

Qualifications

• PhD or MD with advanced degree in Biomedical Sciences or Public Health preferred.
• Minimum 15 years in Epidemiology/Benefit-Risk Evaluation with pharma exposure.
• Minimum 12 years if MD degree; leadership in external partnerships highly valued.
• Strong publication record and experience with regulatory interactions.

Responsibilities

• Lead Epidemiology and BR strategies for safety issues across GBUs.
• Ensure PASS studies and BR evaluations meet regulatory requirements.
• Oversee BR governance bodies and strategic vision for PSPV.
• Develop and implement epidemiology/BR strategy with cross-functional teams.
• Build world-class Epi & BR organization, career development, and budget oversight.
• Lead external collaborations to influence policy and scientific standards.
• Present and engage with regulators, academia, and public-private partners.
• Advance real-world data strategies for rapid analysis in safety studies.

Skills

Leadership

Team management

Analytical thinking

Biostatistics

Regulatory knowledge

Real-world data

Public health

External partnerships

Strategic thinking

Education

PhD in Biomedical Sciences

MD with advanced degree

Job description

Our Team

The Pharmacovigilance and Patient Safety (PSPV) aspiration is to be a cutting-age safety group, to enable us to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers.

Job Title

Vice President

Location

Morristown, NJ

Overview

The Pharmacovigilance and Patient Safety (PSPV) aspiration is to be a cutting-age safety group, to enable us to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers. The Benefit-Risk and Pharmacoepidemiology (BR & PVEpi) team is an international group of experts in process, method and technology experts dedicated to supporting Patient Safety and Pharmacovigilance supporting safety signal management and monitoring of product benefit-risk throughout the product lifecycle. The Head BR & PVEpi is accountable in delivering values through ensuring scientific excellence of pharmacoepidemiology and benefit-risk practices for product development and marketed products while meeting requirements in the field of pharmacovigilance. The Head BR & PVEpi is to provide overall epidemiology, and Benefit-Risk strategy for all GBUs , and is leading innovation in new analytics and tools in the field shaping the standards and policies of Benefit-Risk and PE through leadership in external collaborations with regulatory authorities, academia, and industry. The Head of BR & PVEpi build a high-performing, multidisciplinary team that partners seamlessly with Evidence Generation, Clinical, Medical Affairs, Regulatory, and Quality.

About the Job

The mission of Epidemiology and Benefit-Risk (Epi & BR) Head is to (1) lead the generation of Epi and BR data required by Regulatory authorities and for Sanofi internal teams to characterize product risks and inform decision at BRAC and the benefit/risk for product in development and marketed products across all GBUs, (2) lead innovations in new methods and tools for safety signal and risk assessment using RWE data, and (3) shape the external policy and guidance in these fields. The HeadEpi & BR Head is accountable for all Epidemiology and BR studies to meet regulatory requirements and for internal decision making for all products throughout the life cycle in development and post-marketing. The Head of Epi & BR provides recommendations to the Chief Safety Officer in the management of safety issues together with the GBU PV Heads. Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

Main Responsibilities

• Provide overall Epidemiology and BR strategies to address safety issues and risk management for all products in all GBUs, in Discovery, Development, and post-marketing settings.
• Be accountable for all Epidemiology safety studies (PASS) to meet regulatory requirements.
• Be accountable for all Epidemiology risk assessments and structured BR evaluations for internal decision making made by all senior company safety governance bodies (BRAC, PSB, MRP-TC)
• Support Chief Safety Officer in developing and implementing overall Epidemiology and BR strategy and vision for PSPV.
• Lead and manage Epi & BR Team: build and maintain teams capability as a world-class Epi & BR organization, manage team members professional and career development, manage budget under Global Pharmacovigilance.
• Serve as company’s leading expert in Epidemiology and Benefit Risk evaluation.
• Provide leadership in various external public-private partnerships to (1) foster and evaluate new approaches, methods, and tool for internal application, (2) shape the policies and agendas consistent with Sanofis scientific and business objectives and (3) maintain and improve Sanofis reputation/image externally.
• Advance Sanofis external reputation in Epi & BR by leading various external collaborations, presenting, and providing lectures in various seminars and conferences, and to regulators and academia as necessary.
• Real-World Data: develop and implement a strategy and process for rapid access and analysis of real-world data sources capable of providing critical data for Epi & BR studies for safety evaluation.

About You

• Ph.D. (or other doctoral degrees such as PharmD, Sc.D. Dr.P.H) Biomedical Sciences or Public Health related fields, or M.D. degree with an advanced degree (masters or doctorate level) in Biomedical Sciences or Public Health related fields (or equivalent) is preferred.
• A minimum of 15 years of overall professional experience in Epidemiology, Benefit-Risk Evaluation, Risk Management, Signal Detection and Management and other fields related to Patient Safety Sciences with a PhD degree.
• A minimum of 12 years of overall professional experience in Epidemiology, Benefit-Risk Evaluation, Risk Management, Signal Detection and Management and other fields related to Patient Safety Sciences with a MD degree.
• A minimum of 8 of this experience would preferably be within the pharmaceutical industry setting is preferred
• Experience in the leadership in external partnerships.
• Experience and proven track records in scientific publications
• This position may require up to 25% overall travel.

Knowledge and skills

• Demonstrated leadership skills including team motivation, team management, ability to problem-solve, take initiatives, and meet challenges.
• Demonstrated management skills especially for a team with a large number of people, diverse fields and complex processes.
• Demonstrate the ability to educate stakeholders and leaders on a complex discipline to ensure adherence and understanding of the results generated from pharmacoepidemiological studies
• Demonstrated abilities to lead scientific activities in pharmaceutical industry, including direct interaction with key regulatory and public health agencies and experience in both post-marketing and clinical development activities.
• Master statistics, biostatistics, or other quantitative skills
• Master critical analytics skills.
• Ability to lead industry or public-private working groups or projects.
• Excellent track records of external partnerships and colla
• Excellent teamwork and interpersonal skills.
• Excellent understanding of real-world data sources, their strengths and limitations
• Excellent understanding of regulatory guidelines (ICH, CIOMS, FDA, EU) on post-authorization safety studies, RMP, data privacy, patient registries, epidemiology data sources and epi study guidelines (i.e. ENCePP).

Why Choose Us

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave
• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.