Real World Evidence Scientific Lead

Job title
:
Real World Evidence Scientific Lead

• Location:
  
  Morristown, NJ, Cambridge, MA

We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world

The Real-World Data & Evidence Science (RWD&ES) team, in General Medicines Medical, serves as an end-to-end strategy and execution partner to solve business problems using real-world data. We partner with cross functional partners to lead end-to-end the planning and execution of real-world evidence (RWE) strategies.

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.

We’re 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.

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.

• 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 areon 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 clearand timely visibility the evidence strategy, study progress and anticipation of challenges and risk mitigation.
• Accountable for supporting Gen Med medical gaps within the Global Integrated Evidence Generation Plans (IEGP).

You are a self-starter who brings your energy, expertise and experience as well as takes an entrepreneurial…