Real-World Evidence Scientific Lead

at  Sanofi US

Job title: Real World Evidence Scientific Lead - Autoimmune Diabetes
Location: Netherlands / Belgium preferred - Other European locations considered
This job offer is accessible to all, regardless of gender.

The Real-World Evidence (RWE) Scientific Lead is an essential scientific position responsible for managing the implementation of cutting-edge, effective, and efficient real world evidence strategy for the development of autoimmune type 1 diabetes (aT1D).
As such, you are responsible for the end-to-end high quality execution of real-world studies, working in close partnership with the global RWE Strategy aT1D Lead and internal and external cross functional collaborators

Your main responsibilities are as follows:

• Partner with the Real-World Evidence Strategy AT1D Lead to deliver the value of RWE for the registration, pre-launch and peri-launch of teplizumab in autoimmune type 1 diabetes.
• Manage the end-to-end planning, execution and communication of specific research studies, ensuring that deliverables are on time, within budget, to specification and of high scientific rigor that demonstrates commitment to quality.
• Deliver strategic scientific input in all stages of RWE study conceptualization through study closure, including study design, cohort construction, protocol & statistical analysis plan development, study operations, data analysis, results interpretation and clinical study report development.
• Collaborate with cross-functional stakeholders and relevant internal and external scientific experts based on specific needs of individual RWE studies to ensure that the real-world data and RWE generation is fit-for-purpose to the intended use, whether for regulatory, market access or clinical use.
• Serve as methodological expert in the design and execution of real-world study plans to address critical evidence generation gaps as well as in-house study methodology expert leveraging opportunities to use innovative RWE study designs and analytics to deliver on critical needs.
• Identify and validate external fit-for-purpose data sources, associated institutions and/or organizations, in collaboration with other members of the RWD&ES team.
• Manage the development of budgets for RWE studies in collaboration with relevant internal and external stakeholders, including RWE Operations, Sanofi Global Hub and/or vendors as appropriate, to support the annual strategic and budget planning process and periodic updates.
• Maintain timely communication and close alignment with team members, partners and stakeholders to ensure clear and timely visibility the evidence strategy, study progress and anticipation of challenges and risk mitigation.
• Accountable for supporting GenMed medical gaps within the Global Integrated Evidence Generation Plans (IEGP)