RWE Project Lead

Sanofi•Cambridge, MA

3d•Onsite

About The Position

Within the Translational Medicine Unit (TMU), under the Evidence Generation and Decision Science (EGDS) group, the Clinical Development RWE team supports Sanofi’s 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 Sanofi’s 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 Sanofi’s 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 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

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.

Nice To Haves

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.

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