Head of Benefit-Risk and Pharmacoepidemiology

Sanofi•Morristown, NJ

9d•Hybrid

About The Position

The Pharmacovigilance and Patient Safety (PSPV) aspiration is to be a cutting-edge 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. 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 Head Epi & 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 Sanofi’s 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.

Requirements

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 (master’s 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
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)

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 team’s 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 Sanofi’s scientific and business objectives and (3) maintain and improve Sanofi’s reputation/image externally.
Advance Sanofi’s 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.
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.