Clinical Outcome Assessment (COA) Lead

Role Summary

Clinical Outcome Assessment (COA) Lead responsible for defining COA endpoint strategies and conducting related activities across programs, assets, or indications. Role evolves with experience and may expand in scope, impact, and exposure.

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 the qualitative and quantitative research projects to close the validation gaps on the selected COA instruments (including vendor management)
• Prepare scientific documents (reports, regulatory documents, publications, etc.) for internal and external communication

Qualifications

• Relevant experience in COA in Pharma/CRO/Consultancy with a track record in COA data analyses and/or creation or validation of COAs and/or COA endpoint strategy implementation
• Knowledge of the drug development process and the regulatory and payer environment (FDA, EMA, local agencies, EUnetHTA, NICE, HAS, G-BA, etc.)

Soft And Technical Skills

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

Education

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

Languages

• Professional English fluency (written and spoken)