Clinical Outcome Assessment (COA) Lead

Role Summary

Clinical Outcome Assessment (COA) Lead responsible for defining COA endpoint strategies and conducting related activities across programs. The role evolves with experience, expanding scope to larger portfolios and more strategic assets or indications. Location: Cambridge, MA or Morristown, NJ (Hybrid policy applies, 3 days/week in office).

Responsibilities

• Contribute to the Target Value Proposition with respect to patient-centric outcomes value messaging
• Contribute to a successful strategy for an innovative product 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 qualitative and quantitative research projects to close validation gaps on selected COA instruments (including vendor management)
• Prepare 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 the organization; participate in creating and delivering COA education for internal partners
• Mentor junior COA scientists, provide direction, and delegate tasks to associate COA scientists
• Implement new methodologies and promote innovative approaches
• Define or update the overarching approach and framework to COA endpoint strategies in strategic areas (e.g., Oncology, I&I, rare diseases)

Qualifications

• Experience ideally expected: relevant COA experience in Pharma/CRO/Consultancy; track record from scientific publications in COA disciplines such as data analyses, creation/validation of COAs, and/or COA endpoint strategy implementation
• Knowledge of the drug development process and regulatory environments (FDA, EMA, local agencies) and payer landscape (e.g., NICE, HAS, G-BA, EUnetHTA)

Skills

• Strong analytical and synthesis skills for qualitative and quantitative data
• Accountability, autonomy, initiative, and hands-on mindset
• Excellent written and verbal communication; ability to interact with cross-functional teams
• Ability to manage multiple priorities, projects, and timelines

Education

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

Languages

• Professional English fluency (written and spoken)