Associate Principal / Principal, Clinical Outcome Assessment (COA) Strategy Consulting
Core
Subject matter expert for Clinical Outcome Assessment (COA) endpoint strategy, development, and regulatory interactions for pharmaceutical and biotechnology sponsors.
Role type
Senior IC clinical strategy consultant (COA)
Builds
COA endpoint strategies, new COA instruments, and regulatory-grade evidence packages
Domain
Healthcare / Clinical Research / Patient-Reported Outcomes
Required skills
COA measurement science, endpoint strategy development, regulatory interaction (FDA), instrument development, qualitative research, mentoring, scientific writing, stakeholder engagement
Preferred skills
Advanced degree (PhD, MD, PharmD, DrPH, MSc), strong publication record, recognized credibility in outcomes research
Technologies
None stated
Responsibilities
Develop COA endpoint strategies across clinical development programs; advise sponsors on FDA meetings and evidence expectations; lead development of new COA instruments from concept to validation; oversee internal project teams and review scientific deliverables; mentor junior consultants; support business development through proposal leadership; maintain external scientific profile through publications and conferences
Seniority
Principal, hands-on IC with strategic advisory