Clinical Outcome Assessment (COA) Lead

Role Summary

Clinical Outcome Assessment (COA) Lead. Location: Cambridge, MA or Morristown, NJ (Hybrid policy applies, 3 days/week in office). The COA Lead defines COA endpoint strategies and leads related activities for specific programs, assets or indications. The role advances patient-centric outcome assessments across development projects and collaborates with regulators and internal stakeholders to inform decision-making.

Responsibilities

• 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)

Qualifications

• Preferred: 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
• Preferred: Knowledge of the drug development process and the regulatory (FDA, EMA, local agencies) and payer environment (EUnetHTA, NICE, HAS, G-BA, other local agencies)

Skills

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

Education

• Required: Relevant advanced academic degree (e.g. doctorate or master degree in psychology, anthropology, sociology, public health, epidemiology, psychometrics, clinical research, physiotherapy, pharmacy, medicine, biostatistics…)
• Required: Professional English fluency (written and spoken)