Real World Evidence Scientific Lead

About the Role

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). 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.

Main Responsibilities

• 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.
• 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 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 and leverage innovative RWE study designs and analytics.
• 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.
• Maintain timely communication and close alignment with team members, partners and stakeholders to ensure clear and timely visibility of 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).

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.

Qualifications

• 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 healthcare data.
• End-to-end project management for real-world studies.
• Understanding of commercial strategy.
• Fluent English is mandatory, a second European language is appreciated.