Job Title Senior Clinical Outcomes Assessment (COA) Lead Location Cambridge, MA or Morristown, NJ Overview The Senior Clinical Outcomes Assessment (COA) Lead will shape the future of medicine by integrating the patient perspective into clinical research. The COA team is part of Sanofi’s Global Research and Development (R&D) and reports to the Patient‑Informed Development & Health Value Translation (PID&HVT) department. The role involves consulting with regulators and key opinion leaders to develop disease conceptual models, select and validate COA instruments, and create briefing books for regulatory consideration. Main Responsibilities Define COA endpoint strategies and lead related activities for specific programs, assets, or indications. Scale responsibilities with experience to include a broader portfolio (TA portfolio) and influence key primary and secondary endpoints. Ensure alignment of COA strategies with external standards (e.g., PFDD), internal priorities, and competitive trends. Actively engage in regulatory and commercial dynamics, communicate the therapeutic area strategic framework, and support the development of Core Outcomes Sets and digital endpoint strategies. Provide scientific quality oversight of deliverables, coach less‑experienced COA scientists, lead internal educational programs, and review documents. Represent the COA team in Sanofi asset and indication strategy meetings, FDA meetings (upon invitation), and cross‑functional initiatives such as CSO, EDO, DBM. Serve as a senior advocate in consortia and pre‑competitive initiatives (e.g., C‑Path). Lead strategic transversal projects and provide senior expertise across methodologies including psychometrics, preference studies, qualitative research, regulatory perspective, and endpoint definition. Qualifications At least 5years of relevant experience in COA within Pharma, CRO, or consultancy, with a proven track record of scientific publications or creation/validation of COA instruments. Advanced academic degree (PhD or master’s) in psychology, anthropology, sociology, public health, epidemiology, psychometrics, clinical research, biostatistics, pharmacy, medicine, or related field. In‑depth knowledge of the drug development process and the regulatory (FDA, EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G‑BA, etc.) environment. Strong analytical, communication, and change‑management skills, with the appetite to drive innovation and manage external and internal networks. Benefits & Compensation Salary range: $178,500.00 – $257,833.33 per year, commensurate with experience. Eligible for company employee benefit programs. Benefits include high‑quality healthcare, prevention and wellness programs, and at least 14 weeks gender‑neutral parental leave. Additional benefits information is available through internal resources. EEO Statement Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative‑action employers committed to a diverse workforce. All qualified applicants receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or military status, or any other characteristic protected by law. #J-18808-Ljbffr