Real World Evidence Scientific Lead

Real World Evidence Scientific Lead

Location:

Morristown, NJ, Cambridge, MA

About the Job

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 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.

About Sanofi

We're an R&D-driven, AI-powered biopharma company committed to improving people's 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 people's lives.

Main Responsibilities:

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 Gen Med medical gaps within the Global Integrated Evidence Generation Plans (IEGP).

About You

You are a self-starter who brings your energy, expertise and experience as well as takes an entrepreneurial approach to solving problems, have a growth mindset and are passionate about unleashing the power of real-world data with data science to improve health.

• Advanced degree in pharmaco-epidemiology, biostatistics, or Health Outcomes (PhD preferred). Education in business is a plus.
• Minimum 5 years in real-world evidence (RWE) generation for pharmaceutical industry with end to end leadership experience
• Strong publication track record in relevant journals.
• Experience across therapeutic areas, including transplant, diabetes, and cardiovascular.

Soft Skills:

• Ability to influence and motivate teams as well as senior leaders.
• Strategic thinking for innovative evidence generation.
• Urgency, ownership, and proactive attitude.

Technical

Skills:

• Expertise in pharmacoepidemiology, HEOR, and RWE study design.
• Working with routinely collected…