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$293k–$424k/yr
Full-time
postgraduate degree
Health insurance, Prevention and wellness programs, Parental leave, Employee benefit programs
Posted 11d ago
Apply by Oct 1
~40 hrs/week
Responsibilities
The Head of Benefit-Risk and Pharmacoepidemiology is responsible for leading epidemiology and benefit-risk strategies to characterize product risks throughout the lifecycle. They will manage a multidisciplinary team, drive innovation in safety analytics, and represent the company in external collaborations with regulatory authorities and academia.
Requirements
Candidates must hold a Ph.D., Pharm.D., Sc.D., Dr.P.H., or M.D. with an advanced degree in a relevant field. A minimum of 8 to 15 years of professional experience in epidemiology, patient safety, and risk management within the pharmaceutical industry is required.
Full job description
Job title: Vice President
Location: Morristown, NJ
Overview:
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.
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 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.
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 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.
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 (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
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 it’s 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.
#GD-SP #LI-SP
#LI-Hybrid #vhd
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here
US and Puerto Rico Residents Only
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.
North America Applicants Only
The salary range for this position is:
$293,250.00 - $423,583.33
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.
We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth.
We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Interactions with this account must comply with the Terms: https://bit.ly/sanofi-terms
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How much do Science & Research jobs in Cambridge, MA pay?
Based on 1041 listings with disclosed salaries, most science & research jobs in Cambridge, MA pay between $94k–$270k per year. Individual offers vary with seniority, company size, and specialization.
How many Science & Research jobs are open in Cambridge, MA right now?
There are currently 1,266 open science & research positions in Cambridge, MA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in Cambridge, MA?
Companies currently hiring include Novartis, Draper, Harvard Division of Medical Sciences, Sanofi, Flagship Pioneering, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Science & Research jobs in Cambridge, MA?
Yes — 498 of the 1266 open science & research positions offer remote or hybrid work (54 remote, 444 hybrid).
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