• Location: Gentilly, France
• Job type: Permanent, Full time

About the job

The Gen Med medical Team at Sanofi is a high-performing team of Medical leaders who are a trusted source of scientific and Medical information and shared insights; effective and innovative strategic partners to our internal and external stakeholders; and dedicated to public health. We represent diverse experiences and backgrounds which strengthens our team and mirrors the healthcare communities we engage.

The Real-World Data & Evidence Science (RWD&ES) team, part of GBU Medical, serves as an end-to-end strategy and execution partner in applying RWE and data science to solve business problems using real-world data. The team serves medical, market access and strategy & new product planning in the strategy, design and execution of evidence and insights, by identifying and sourcing fit-for-purpose data as well as designing evidence strategy and conducting real-world studies to deliver impact for customers, including patients, physicians, payers and regulators. This team is at the forefront of unlocking value from real-world data and translating data into insights and evidence to better understand patient needs, change the practice of medicine, inform regulatory and access decision-making and ultimately improve health outcomes.

Main responsibilities:

As a member of the Gen Med France Medical Team and contributor to the medical evidence generation community, the RWE Medical lead builds on training and experience in health sciences and epidemiology research, public health, and regulations to ensure that relevant medical evidence is available and strategically used to support the development, launch and commercialization of drugs/vaccines throughout the entire product lifecycle, in the designated TA scope.

• Be the local medical RWE expert and central connection with global RWE experts to ensure excellence in execution on brand RWE strategies, especially for pre-launch periods and launch brands, data strategies and RWE transformational initiatives
• Develop and implement strategies for the identification, collection, evaluation and analysis of real-world data (RWD) sources in France, to support various research initiatives and business objectives at MCO level, aligned with global brand and RWE strategies
• Collaborate cross-functionally with internal stakeholders including clinical research units, medical affairs, market access, and commercial teams to identify research questions and generate evidence-based insights
• Design and oversee observational studies, registries, and other real-world evidence-generating activities, including retrospective analysis of existing databases, ensuring compliance with regulatory requirements and ethical standards
• Identify and evaluate local data gaps and opportunities in partnership with the global RW Data Strategy & Partnership Lead and Evidence Strategy Leads, that is fit-for-purpose to identified evidence gaps from brand IEGPs and the RWE data strategy
• Manage relationships with external vendors, including contract research organizations (CROs), data providers, and academic institutions, to facilitate data acquisition, processing and analysis
• Lead the analysis and interpretation of real-world data, employing advanced statistical methods and epidemiological techniques to derive meaningful insights, in collaboration with internal and external experts
• Participating in external scientific engagement and maintaining at France level, to facilitate the collection of insights, challenges and best practices, as well as to deliver opportunities to shape the external acceptability of RWE
• Prepare and present findings from real-world evidence studies to internal and external stakeholders, including scientific conferences, ministries of health, regulatory agencies, and healthcare providers
• Lead the local upskilling of RWE with global initiatives, events and learning opportunities, coordinated with the global upskilling in RWE strategic initiative. Create and organize local activities to enhance learner motivation and deliver an effective learning experience
• Stay abreast of developments in real-world evidence methodologies, advances in data science, regulatory guidance, and healthcare data trends, and integrate relevant insights into project planning and execution
• Contribute to the development of real-world evidence strategies relevant to France and integrated evidence generation plans to support product development, regulatory submissions, and market access efforts
• Represent global RWE in country medical leadership team to facilitate seamless communication, coordinate and alignment of RWE with medical strategies and changing business needs
• Provide guidance and support to cross-functional teams on the use and interpretation of real-world evidence in decision-making processes
• Drive the timely execution of the RWE operational plan
• Foster a culture of evidence-based decision-making by promoting the value of real-world data and evidence within the organization and with external stakeholders, work on the development of local databases if relevant