RWE Project Lead

BioSpace; Cambridge (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Sanofi in Cambridge, MA, is seeking a Clinical Development RWE Project Lead to drive real-world evidence programs across therapeutic areas. You will lead cross-functional teams, design data-driven strategies, and ensure alignment with regulatory expectations within our EGDS organization.

Successful candidates will have 2+ years in real-world/clinical projects, strong project management, and deep understanding of RWE, data analytics and regulatory considerations.

Qualifications

• PhD, or MSc, in Health Sciences with quantitative background or Public Health.
• Minimum 2 years of previous experience in Real World/clinical project in industry.
• Understanding of TA relevant to Sanofi context (such as I&I, Neuroscience or rare diseases).
• Understanding of RWE, data analytics and statistics.
• Understanding of legal and regulatory environment influencing clinical development plans.

Responsibilities

• Lead multidisciplinary teams and manage project execution timelines.
• Coordinate with RWE portfolio Heads, GPTs and other stakeholders to design project MVP goals and deliverables.
• Create project business cases, document and report project activities and define system requirements and dependencies.
• Ensure access modalities to fit-for-purpose datasets in collaboration with Sanofi stakeholders.
• Drive external interactions to promote RWE adoption at FDA/EMA levels.

Skills

RWE knowledge

Project management

Statistical analysis

Regulatory awareness

Stakeholder management

Leadership

Communication

Education

PhD or MSc in Health Sciences

Tools

Big data tech

AI platforms

Job description

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.

Job Title

RWE Project Lead

Location

Cambridge, MA

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 the 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 actionabe 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 TAs.
• 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

Main 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 Aff.\t
Affirmative 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 commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.