Clinical Outcomes Assessment Lead

Job Title

Clinical Outcomes Assessment Lead

Cambridge, MA;
Morristown, NJ

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.

• The remit of the Clinical Outcome Assessment (COA) team at Sanofi is to incorporate the patients’ perspective (and other subjective perspectives) into clinical research through the utilization of Clinical Outcome Assessments (COAs) and other methods.
• The COA team is part of Sanofi’s Global Research and Development (R&D), and reports into the Patient‑Informed Development & Health Value Translation (PID&HVT) department.
• Consultation with regulators and key opinion leaders is common.
• Example research activities for the COA team include the development of a disease conceptual model; the selection of COA instruments to measure specific concepts of interest; the psychometric assessment of the measurement properties of a COA instrument; the development and validation of new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs…
• Internal customers include primarily Research and Development (R&D), Health Economics and Value Assessment (HEVA), and also Medical Affairs, Market Access, Biostatistics, and Commercial.

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.

The COA Lead is accountable for the definition of COA endpoint strategies and responsible for the conduct of related activities in relation to specific programs, assets or indications. The scope evolves as the COA Lead gains experience in the role and demonstrates ability to take more in quantity (TA portfolio), impact (primary and key secondary endpoints) and exposure (strategic assets or indications).

• Contribute to the Target Value Proposition with respect to patient‑centric outcomes value messaging
• Contribute to a successful strategy for innovative product by an optimized COA endpoint strategy aligned with Sanofi’s Best In Class / First In Class approach
• Generate a comprehensive understanding of a disease and treatment paradigm through primary and secondary research
• Advise on the use and/or development of Fit‑for‑Purpose COA instruments in clinical research projects; including gap analyses, implementation, statistical analyses, psychometric validation and dissemination
• Manage the qualitative and quantitative research projects to close the validation gap(s) on the selected COA instruments (including vendor management)
• Prepare the scientific documents (reports, regulatory documents, publications,…) for internal and external communication

• Leads specific internal organizational initiatives, within COA and PID‑HVT (eg. RACI, templates, guidance)
• Advocate for the role of quantitative and qualitative COA across Sanofi, participate in creating and delivering education on COAs for internal business partners
• Mentor more junior COA scientists, share specific knowledge and expertise with the COA team; provide direction and delegate specific tasks to associate COA scientist
• Implement new methodologies and promote innovative approaches.
• Define or update overarching approach and framework to COA endpoints strategies in strategic area (eg Oncology, I&I, rare diseases)

• Relevant experience in COA in Pharma/CRO/Consultancy: ideally proven track record from scientific publications in core COA disciplines such as COA data analyses and/or creation or validation of new COAs and/or COA endpoint strategy implementation
• Knowledge of the drug development process and the regulatory (FDA, EMA, local…