Develop COA endpoint strategies across clinical development programs.
Differentiate proposals through expert-driven COA strategy narratives.
Advise sponsors on development and justification of COA endpoint strategies for regulatory interactions.
Lead and advise on drafting and refinement of COA instrument items.
Oversee qualitative research activities supporting content validity.
Serve as subject matter expert overseeing internal project teams executing COA strategy and development work.
Support business development through proposal leadership and client presentations.
Maintain a strong external profile through publications and scientific collaborations.

Deep expertise across COA types (PRO, ObsRO, ClinRO, PerfO) and their application in clinical research.
Extensive experience developing COA endpoint strategies across multiple therapeutic areas.
Hands-on experience developing new COA instruments, including item writing and qualitative validation.
Experience supporting FDA-facing endpoint strategy and regulatory interactions.
Ability to mentor junior team members.
Excellent scientific writing, presentation, and stakeholder engagement skills.
Advanced degree (PhD, MD, PharmD, DrPH, MSc) in a relevant scientific discipline strongly preferred.
Strong publication record and recognized credibility in outcomes research or COA measurement science.
Well-developed written and verbal communication skills including presentations, chairing meetings, external conference presentations, workshop facilitation, business and report writing.

Associate Principal, Patient Centered Solutions

Key skills