RWE Project Lead

BioSpace; Morristown (NJ); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health benefits

Parental leave (14+ weeks)

International opportunities

Job summary

Sanofi in Morristown, NJ seeks an RWE Project Lead to drive real‑world evidence programs across translational medicine. You will lead cross‑functional teams, collaborate with GPTs, regulatory and research units, and ensure delivery of high‑impact RWE studies aligned with developmental needs.

You will influence project planning, design roadmaps, and identify external data sources to support decision making and regulatory interactions across Sanofi pipelines.

Qualifications

• PhD or MSc in Health Sciences with quantitative background.
• Strong knowledge of real-world evidence and analytics.
• Understanding of regulatory environment influencing clinical development.
• Proven capability to deliver complex projects.
• Excellent communication and stakeholder influencing skills.

Responsibilities

• Lead high‑impact RWE projects within Translational Medicine Unit (TMU).
• Drive RWE projects prioritized by Clinical Development RWE Portfolio Heads.
• Collaborate with GPTs, Clinical Science Organization, Research, Digital Office and Regulatory teams.
• Execute project‑specific roadmaps to ensure deliverables.</li>
• Sourcing data needed to run projects and translating findings into actions.

Skills

RWE knowledge

Data analytics

Statistics

Project management

Communication & influencing

Education

PhD or MSc in Health Sciences with epidemiology/public health

Job description

Our Team:

Within the Translational Medicine Unit (TMU), under the Evidence Generation and Decision Science (EGDS) group, the Clinical Development RWE team supports Sanofis clinical development efforts by leveraging real-world data and evidence to generate insights that inform drug development and support evidence-based decision making. The team collaborates closely with other functional areas, including biostatistics, clinical, digital, research, translational medicine, commercial and medical affairs, to lead RWE evidence generation addressing critical clinical questions.

Job Title

RWE Project lead

Location

Morristown, NJ

About The Job

Within the Translational Medicine Unit (TMU), under the Evidence Generation and Decision Science (EGDS) group, the Clinical Development RWE team supports Sanofis clinical development efforts by leveraging real-world data and evidence to generate insights that inform drug development and support evidence-based decision making. The team collaborates closely with other functional areas, including biostatistics, clinical, digital, research, translational medicine, commercial and medical affairs, to lead RWE evidence generation addressing critical clinical questions.

Our mission is to deliver high impact RWE to enhance clinical development plans, inform regulatory decisions, and support drug positioning. We do this by leveraging a range of data sources and analytical techniques, to generate insights that inform drug development and support decision making. Our work contributes to advancing Sanofis goal of improving patient lives through innovative treatments.

What is unique about our team? Our team brings together expertise in clinical development, RWE, Data science, and analytics to generate insights that support decision making across the clinical development value chain. We work closely with other functions to design and execute and drive impact of RWE studies that address key questions for Sanofis pipeline. Additionally, we are committed to staying at the forefront of RWE science and continuously advancing our capabilities to deliver high quality, impactful insights.

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

Main Responsibilities

• Working with Clinical Development RWE Portfolio Heads, the Clinical Development RWE Project Lead (CDRPL) will work at project level within specific TAs and across functions to lead high-impact projects, leveraging core RWE AI evidence generation platforms and other RWE assets, based on clinical development needs and current/future pipeline.
• The CDRPL will drive RWE projects prioritized by Clinical Development RWE Portfolio Heads, based on evidence needs for clinical development and current/future molecule pipeline, by leveraging one of the core RWE evidence generation platforms.
• He/She will also work in close contact with other internal partners such as Global Project Team (GPT) members, Clinical Science Organization, Research, Digital Office and Global Regulatory teams to ensure the needs and ambitions of TAs and assets are fulfilled.
• The CDRPL will execute the project-specific roadmap to ensure successful delivery of the project.
• He/She will have to bring value by bringing to GPTs project deliverables, highlight and execute portfolio strategies to source data needed to run projects.

Focusing Efforts In The Following Areas

Delivery of RWE evidence generation projects for relevant therapeutic areas

• Lead multidisciplinary teams, ensuring effective project execution plan and timelines.
• Coordinate with RWE portfolio Heads, GPTs and other key stakeholders to design project minimum viable product: identify, understand and address user needs, ensuring alignment among stakeholders and translating them into actionable project goals and deliverables.
• Create project business cases, document and report project activities and define system requirements and dependencies with other projects.

Contribution to RWE portfolio and platforms strategy within relevant therapeutic areas

• Inform roadmap for the RWE platform projects by overseeing the end-to-end development of project and dependencies
• Ensure access modalities to fit-for-purpose datasets, in collaboration with relevant Sanofi stakeholders in relevant TA's.
• Have external facing interactions to drive adoption of RWE in clinical development, at FDA/EMA level.

Interact with external policy groups in collaboration with Regulatory function

• Generate/discuss regulatory and other RW Evidence packages
• Ensure proper dissemination and use of study outputs to best support Clinical Development objectives.

About You

Basic Qualifications

• PhD, or MSc, in Health Sciences with quantitative background, Epidemiology or Public Health.
• Minimum 2 years of previous experience in Real Word/clinical project in industry required.
• Proven capability to deliver complex projects.
• Understanding of TA relevant to Sanofi context (such as I&I, Neuroscience or rare diseases), current needs and latest innovations in clinical development and evidence generation.
• Understanding of RWE, data analytics and statistics.
• Understanding of legal and regulatory environment influencing clinical development plans, labelling and promotional claim. Past experience / excitement around big data / modern tech stack environment.

Preferred Qualifications

• Well-developed conceptual thinking skills with capability to access internal and external resources.
• Successful experience working in a global and matrixed environment.
• Excellent communication and influencing skills, with ability to collaborate externally and internally with key customers and stakeholders.
• Strong project management skills and experience.
• Proven leadership and stakeholder management skills.
• Innovative mindset.

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.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affiantive Action employers committed to a culturally diverse 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 commens