Clinical Outcome Assessment Director

Job Summary

To develop and execute COA strategies for assigned clinical programs, the full-time Associate Director, Clinical Outcome Assessment will apply qualitative and quantitative methods, manage endpoint selection, and collaborate with cross-functional teams in a remote capacity.

Key responsibilities:

• Identify and implement fit-for-purpose COAs for clinical programs, ensuring alignment with regulatory submissions and value evidence needs
• Design and lead the generation of COA evidence, contributing to regulatory dossiers and external stakeholder communications
• Serve as the COA point of contact on clinical study teams, representing COA in program governance and external conferences

Required qualifications:

• Bachelor's degree in outcomes research, health services research, epidemiology, psychology, public health, or a related field
• 7+ years of relevant experience in COA/PRO or patient-centered outcomes research, with at least 5 years in COA work
• Demonstrated experience in designing and executing COA evidence-generation projects independently
• Working knowledge of FDA/EMA patient-focused drug development guidances
• Comprehensive understanding of the pharmaceutical industry and regulatory requirements globally