Senior Clinical Outcomes Assessment; COA Lead

Role Summary

The Senior Clinical Outcomes Assessment (COA) Lead defines COA endpoint strategies and leads related activities across programs, assets or indications. The role grows in scope as experience increases, expanding impact and exposure to strategic assets or indications. The Senior COA Lead provides expertise and strategic input within the COA team, ensures alignment with external standards and internal priorities, and represents the COA team in asset strategy meetings and regulatory discussions.

The role also coaches junior scientists, leads internal educational programs, and may take direct accountability for certain assets with COA support.

• The COA Lead is accountable for defining COA endpoint strategies and conducting related activities for specific programs, assets or indications, with scope evolving over time.
• The Senior COA Lead provides expertise and strategic input beyond the COA team, ensuring alignment with external standards, internal priorities, and market trends.
• Participates in regulatory and commercial dynamics for the therapeutic area, defines and communicates the strategic framework (including Core Outcomes Sets and Digital endpoint strategy), and guides COA scientists.
• Ensures scientific quality of activities and deliverables within defined scope; coaches less experienced COA scientists, leads internal educational programs, reviews documents, and represents the COA team in asset strategy meetings and FDA meetings when invited.
• Direct accountability for some assets with COA scientist support.
• Delivers senior expertise across methodologies (e.g., Psychometrics, Preference studies, Qualitative Research, Regulatory perspective, Endpoint definition).
• Leads strategic transversal projects and represents the COA team in cross-functional initiatives and pre-competitive consortia (e.g., C-Path).

• Required:
  
  5+ years of relevant experience in COA in Pharma/CRO/Consultancy.
• Required:
  
  Ideally a proven track record from scientific publications in core COA disciplines (COA data analyses and/or creation or validation of new COAs and/or COA endpoint strategy implementation).
• Required:
  
  Knowledge of the drug development process and the regulatory and payer environment (FDA, EMA, local agencies; EUnetHTA, NICE, HAS, G-BA, etc.).

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

• Appetite for innovation and change management.
• Ability to interact with and manage external and internal networks.