Real World Evidence Strategy Lead

Sanofi•Morristown, NJ

4d•Hybrid

About The Position

As the Real-World Evidence (RWE) Strategy Lead, you will establish and execute RWE strategies across global Therapeutic Areas, translating medical needs into evidence that drives regulatory, access and medical decisions. Working in close partnership across Medical, Market Access, Health Economics Value and Access, and other cross-functional Brand teams, you lead through influence to deliver innovative, scientifically rigorous real-world studies that generate critical insights and measurable business impact. The Real-World Evidence (RWE) team in OneMedical 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. Operating across both our General Medicines (GenMed) and Specialty Care Global Business Units, our RWE team sits at the intersection of data science, medical strategy, and scientific leadership, translating complex real-world data into meaningful insights that drive patient outcomes. We are on an ambitious journey to build a best-in-class RWE capability, harnessing innovative methodologies, cutting-edge real-world data sources, and AI-powered analytics to stay at the forefront of evidence generation. 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.

Requirements

Advanced degree in pharmaco-epidemiology, biostatistics, Health Outcomes, or equivalent discipline. PhD is preferred.
Formal education in business or management is desirable.
At least 10 years real-world evidence generation in or for the pharmaceutical industry.
End-to-end leadership of RWE studies from concept to study completion and publication for regulatory or reimbursement submissions.
Use of innovative RWE methodologies to address evidence gaps.
Significant peer reviewed publication track record in epidemiology, clinical, statistical and/or HEOR journals required.
Experience working in multiple therapeutic areas – experience in Immunology, Rare Diseases, Oncology, Neurology, Ophthalmology is highly valued.
Cross-functional collaboration and alignment in complex global matrix teams.
Strategic and visionary thinking to shape, influence and articulate innovative evidence generation.
Systemic thinking and focus on impact.
Strong sense of urgency, ownership and proactive attitude to deliver value to our brands.
Ability to influence, engage and motivate teams as well as senior leaders through personal advocacy, vision and drive.
Ability to adapt and communicate messages to a wide range of audiences at all levels (both scientific and commercial), inside and outside of the organization, to convince others of the value of our brands.
Ability to effectively negotiate and compromise with internal and external stakeholders to achieve optimal results for the business, agile to change, and obtain and manage budgets.
Apply growth mindset to develop new skills or knowledge.
Demonstrated expertise in pharmacoepidemiology, HEOR and RWE study designs and methodologies, including innovative techniques.
Experience working with routinely collected data (claims databases, electronic medical health records, registries and various structured and possibly unstructured sources in the healthcare sector within pharmaceutical company settings.
Ability to build an evidence strategy from business needs and translate into study requirements.
End-to-end project management of real-world studies and management reporting.
Good working knowledge of the commercial strategy (i.e. market share, competitors, product positioning) and ability to adapt evidence strategy in anticipation of market changes.
Fluency in spoken and written business English mandatory.
Proficiency or working knowledge of French or other European languages a plus.

Responsibilities

Build the asset / brand RWE strategy in alignment with the global disease area strategy; translate medical needs into evidence requirements that is fit for intended purposes for clinical, or regulatory decision-making.
Accountable for supporting GenMed medical gaps within the Global Integrated Evidence Generation Plans (IEGP).
Partner with Global Medical Lead(s) to ensure robust integrated evidence generation plans (IEGP) that are built with timely and relevant contributions from internal and external global and local experts; and that IEGPs are communicated and documented consistently across strategic plans, brand plans and medical plans.
Develop data strategy that enables the realization of the evidence strategy; determine data availability, access and suitability from internal and external sources, in collaboration with the Real-World Data Strategic Partnership Lead as needed.
Build an understanding of TA lead and follow on indications with real-world data to deliver insights that support scientific and business decision-making and launch readiness.
Conduct initial data landscaping, assessment and preparation for RWE strategies in future new indications and/or formulations as the asset / brand strategy develops and the TA strategy evolves.
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 across the Sanofi ecosystem (AI, platforms, digital, etc.), internal teams and external service providers using innovative RWE study designs and analytics to deliver on critical needs.
Deliver strong pre- and peri-launch support to prioritized countries for asset / brand to inform clinical guidelines and drive medical adoption.
Develop defensible budgets for real-world 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 (final accountability for budget remains with Medical franchise Head).
Manage the end-to-end execution of real-world studies ensuring deliverables are on time, within budget, to specification and of high scientific rigor that demonstrates commitment to quality.
Work seamlessly with partners and stakeholders to influence in the matrix organization and identify solutions in an optimal and efficient manner; synergize and optimize resources and efforts where appropriate.
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.
Represent Sanofi’s RWE capabililities externally e.g. scientific congresses, discussions with regulatory bodies, etc.
Contribute to building /transforming the RWE culture/capability at enterprise level