Clinical Outcome Assessment (COA) Lead

Role Summary

The Clinical Outcome Assessment (COA) Lead defines COA endpoint strategies and leads related activities across programs, assets, or indications. The role evolves with experience to handle increasing scope, impact, and exposure within strategic areas.

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 address validation gaps for 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 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 strategies in strategic areas (e.g., Oncology, I&I, rare diseases)

Qualifications

• Relevant experience in COA in Pharma/CRO/Consultancy; proven track record from scientific publications in core COA disciplines 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.)
• Strong analytical and synthesis skills of qualitative and quantitative data
• Accountability, autonomy, initiative, and ability to manage multiple priorities and projects
• Excellent written and oral communication skills
• Professional English fluency (written and spoken)

Skills

• Strong analytical and synthesis skills of qualitative and quantitative data
• Autonomy, accountability, and initiative
• Interpersonal and communication skills (written and oral)
• Ability to manage multiple priorities and timelines

Education

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

Languages

• Professional English fluency (written and spoken)