Associate Principal / Principal – Clinical Outcome Assessment Strategy Consulting

About the role

The Associate Principal/Principal will act as the subject‑matter expert for Clinical Outcome Assessment (COA) endpoint strategy, regulatory strategy and instrument science. The role supports pharmaceutical and biotechnology sponsors by designing scientifically rigorous COA solutions that drive patient‑centric drug development and regulatory success.

Key responsibilities

• Develop and position primary and secondary COA endpoints across clinical development programs and client proposals.
• Advise sponsors on regulatory interactions, prepare for FDA meetings and translate evidence expectations into actionable strategies.
• Lead the design, item writing, qualitative validation and scoring of new COA instruments from concept to validation‑ready tools.
• Oversee internal project teams, review scientific deliverables and mentor junior COA consultants.
• Support business development through proposal leadership, solution design and client presentations.
• Maintain an external scientific profile by publishing, presenting at conferences and participating in advisory boards.

Required profile

• Deep expertise across COA types (PRO, ObsRO, ClinRO, PerfO) and extensive experience developing COA endpoint strategies in multiple therapeutic areas.
• Hands‑on experience creating new COA instruments, including item development and qualitative validation.
• Experience supporting FDA‑facing endpoint strategy and regulatory interactions.
• Advanced degree (PhD, MD, PharmD, DrPH, MSc) in a relevant scientific discipline is strongly preferred.
• Strong publication record and recognized credibility in outcomes research or COA measurement science.
• Ability to mentor junior team members and communicate complex scientific concepts to diverse stakeholders.