Associate Principal / Principal, Clinical Outcome Assessment (COA) Strategy Consulting
Core
Subject matter expert for Clinical Outcome Assessment (COA) endpoint strategy, instrument development, and regulatory interactions to support pharmaceutical and biotechnology sponsors in developing new medicines.
Role type
Senior IC clinical research strategy consultant (COA)
Builds
Scientifically rigorous COA strategies, new COA instruments, and regulatory-grade evidence packages for clinical development programs.
Domain
Life sciences / Clinical research / Patient-reported outcomes
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
COA measurement science expertise, FDA regulatory strategy, qualitative research design, instrument development, scientific writing, stakeholder engagement, team mentorship
Preferred skills
Advanced degree (PhD, MD, PharmD, DrPH, MSc), strong publication record, recognized credibility in outcomes research
Technologies
None explicitly listed
Responsibilities
Develop COA endpoint strategies for clinical development programs; advise sponsors on FDA interactions and evidence expectations; lead development of new COA instruments from concept to validation; oversee internal project teams and review scientific deliverables; support business development through proposal leadership and client presentations; maintain external scientific profile through publications and conferences
Seniority
Principal, hands-on IC with strategic advisory and mentorship
