Associate Principal / Principal, Clinical Outcome Assessment (COA) Strategy Consulting

Overview

As an Associate Principal/Principal COA Endpoint Strategy, you will serve as the COA subject matter expert across development programs and regulatory interactions. You will lead the design and justification of COA endpoints, guide instrument development, and mentor teams in scientific rigor. You will act as a trusted external thought leader, translating regulatory expectations into actionable client recommendations. This role sits at the intersection of strategy, science, and client delivery, with impact on patient-centered outcomes and regulatory success.

Responsibilities

• Develop COA endpoint strategies across clinical programs, including primary and key secondary endpoints
• Incorporate COA expertise into client meetings and workshops
• Differentiate client solutions through COA strategy narratives
• Translate emerging scientific and regulatory expectations into recommendations
• Advise on regulatory-grade COA strategies and engage in FDA meetings as SME
• Lead development of new COA instruments from concept to validation-ready tools
• Draft and refine COA instrument items and scoring approaches
• Oversee qualitative research for content validity (concept elicitation, cognitive interviewing)
• Ensure COA instruments are patient-centered and fit-for-purpose for clinical/regulatory use
• Oversee internal project teams, review scientific deliverables for quality
• Mentor COA consultants and support capability development
• Support business development through proposal leadership and solution design
• Maintain external visibility via publications, conferences, and collaborations

Key requirements

• Deep expertise across COA types (PRO, ObsRO, ClinRO, PerfO)
• Experience developing COA endpoints across multiple therapeutic areas
• Hands-on COA instrument development 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
• Advanced degree (PhD, MD, PharmD, DrPH, MSc) strongly preferred
• Strong publication record and credibility in outcomes research or COA science
• Strong communication skills in meetings, conferences, and workshops
• Entrepreneurial mindset for new client offerings and capabilities

• strategic thinking
• stakeholder engagement
• mentoring and leadership
• COA measurement science
• instrument development
• qualitative validation

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