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

About the role

The Associate Principal / Principal Clinical Outcome Assessment (COA) Endpoint Strategy role is a subject matter expert position within IQVIA's Patient Centered Solutions team. It covers COA endpoint strategy, endpoint development, COA regulatory strategy and COA instrument science in client engagement and project delivery. The role advises pharmaceutical and biotechnology sponsors and represents IQVIA as an external scientific thought leader.

Key responsibilities

• Develop COA endpoint strategies across clinical development programs, including primary and key secondary endpoint positioning, and bring COA expertise into client meetings, workshops and strategic discussions.
• Differentiate proposals and client solutions through expert-driven COA strategy narratives and translate emerging scientific and regulatory expectations into actionable recommendations.
• Advise sponsors on development and justification of COA endpoint strategies for regulatory interactions, support preparation for and participation in FDA meetings, and guide sponsors on evidence expectations and fit-for-purpose strategies.
• Lead the development of new COA instruments from concept to validation-ready tools, including item writing, response options, recall periods and scoring approaches, and oversee qualitative research such as concept elicitation and cognitive interviewing.
• Oversee internal project teams, review and approve key scientific deliverables, and mentor and coach COA consultants.
• Support business development through proposal leadership, solution design and client presentations, and contribute to evolving COA methodology and reusable assets.
• Maintain an external profile through publications, conference presentations and collaborations, and contribute to teaching, advisory boards or industry working groups where appropriate.

Required profile

• 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.
• 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.

Required skills

• Excellent scientific writing, presentation and stakeholder engagement skills.
• Written and verbal communication, including presentations, chairing meetings, external conference presentations, workshop facilitation, business and report writing.
• An entrepreneurial nature and interest in developing new client offerings and solutions.