Clinical Outcome Assessment (COA) Lead

Role Summary

Clinical Outcome Assessment (COA) Lead responsible for defining COA endpoint strategies and leading related activities for specific programs. The COA team integrates the patient perspective into clinical research and sits within Global R&D under the PID-HVT department. Location: Cambridge, MA or Morristown, NJ (Hybrid policy applies, 3 days/week in office).

Responsibilities

• 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.
• As experience grows, expand scope across the TA portfolio, impact on primary and key secondary endpoints, and exposure to 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 products by an optimized COA endpoint strategy aligned with Best In Class / First In Class approaches.
• 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.
• Lead internal organizational initiatives within COA and PID-HVT (e.g., RACI, templates, guidance).
• Advocate for the role of quantitative and qualitative COA across Sanofi and contribute to education on COAs for internal business partners.
• Mentor junior COA scientists, provide direction, and delegate tasks to associate COA scientists.
• Implement new methodologies and promote innovative approaches.
• Define or update overarching COA endpoint strategies in strategic areas (e.g., Oncology, I&I, rare diseases).

Qualifications

• Relevant experience in COA in Pharma/CRO/Consultancy, with a track record in COA data analyses and/or creation/validation of COAs and/or COA endpoint strategy implementation.
• Knowledge of the drug development process and regulatory and payer environments (FDA, EMA, local agencies; EUnetHTA, NICE, HAS, G-BA, etc.).
• Professional English fluency (written and spoken).

Skills

• Strong analytical and synthesis skills of qualitative and quantitative data.
• Accountability, autonomy, initiative, and hands-on mindset.
• Good interpersonal and written/oral communication skills.
• Ability to manage multiple priorities and projects, balancing workload and timelines.

Education

• Relevant advanced academic degree (e.g., doctorate or master's) in psychology, anthropology, sociology, public health, epidemiology, psychometrics, clinical research, physiotherapy, pharmacy, medicine, biostatistics, or related fields.