Clinical Outcome Assessment (COA) Lead

Role Summary

The Clinical Outcome Assessment (COA) Lead is responsible for defining COA endpoint strategies and overseeing related activities across programs, assets, or indications. The role evolves with experience, expanding scope to larger portfolios and strategic assets, and requires collaboration with internal partners to integrate patient-centric outcomes into clinical research.

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 optimizing 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 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 quantitative and qualitative COA across the organization and contribute to 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 overarching COA endpoint strategy frameworks for strategic areas (e.g., Oncology, I&I, rare diseases)

Qualifications

• Relevant experience in COA within Pharma/CRO/Consultancy, including evidence of COA data analyses, creation or validation of COAs, and COA endpoint strategy implementation
• Knowledge of the drug development process and regulatory (FDA, EMA, local agencies) and payer (e.g., NICE, HAS, G-BA, EUnetHTA) environments

Skills

• Strong analytical and synthesis skills for qualitative and quantitative data
• Accountability, autonomy, initiative, and hands-on mindset
• Excellent interpersonal and written/spoken communication skills
• Ability to manage multiple priorities and projects, and to balance workload and timelines

Education

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

Languages

• Professional English fluency (written and spoken)