Real World Evidence Scientific Lead

About the Job

The Real-World Evidence (RWE) team in One Medical Pharmacovigilance and Patient Safety (PSPV) 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 planning and execution of RWE strategies.

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 RWE strategy. You are responsible for the end-to-end high-quality execution of real-world studies, working in close partnership with the global RWE Strategy Leads and internal and external cross functional collaborators.

• Partner with the Real-World Evidence Strategy Leads to deliver the value of RWE for the registration, pre-launch and peri-launch of treatments in therapeutic areas that include Type 1 diabetes, transplant, cardiovascular and metabolic disease, neurology, oncology, immunology, rare disease, insulin-based therapies and alliance. The focus of this role will be mainly in Transplant and Oncology.
• 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 OneMedical PSPV 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 OneMedical PSPV 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).
• 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.