Senior COA Strategy & Endpoint Innovation Leader

IQVIA Inc; Bordeaux; Hybrid; EUR 120,000 - 180,000; Full time

Job summary

IQVIA in multiple locations seeks an Associate Principal/Principal Clinical Outcome Assessment (COA) Endpoint Strategy expert to lead COA strategy, instrument development, and regulatory engagements. You will guide client programs, mentor teams, and contribute to scientific leadership across therapeutic areas.

You will collaborate with pharma sponsors, design robust COA strategies, and ensure patient-centered, regulatory-ready endpoints that support drug development and approvals.

Qualifications

• Deep expertise across COA types and their clinical research applications.
• Extensive experience developing COA endpoint strategies across therapeutic areas.
• Hands-on experience developing new COA instruments, item writing, and qualitative validation.
• Experience supporting FDA-facing endpoint strategy and regulatory interactions.
• Ability to mentor junior team members and lead scientific deliverables.

Responsibilities

• Develop COA endpoint strategies across clinical development programs and regulatory contexts.
• Lead COA instrument development from concept to validation-ready tools.
• Oversee qualitative research supporting content validity (concept elicitation, cognitive interviewing).
• Mentor COA consultants and ensure quality of scientific deliverables.
• Support business development through proposal leadership and client interactions.

Skills

COA types (PRO, ObsRO, ClinRO, PerfO)

COA endpoint strategies

FDA engagement experience

mentoring junior team

scientific writing & presentations

Education

PhD/MD/PharmD/DrPH/MSc in a relevant field

Job description

IQVIA in multiple locations seeks an Associate Principal/Principal Clinical Outcome Assessment (COA) Endpoint Strategy expert to lead COA strategy, instrument development, and regulatory engagements. You will guide client programs, mentor teams, and contribute to scientific leadership across therapeutic areas.

You will collaborate with pharma sponsors, design robust COA strategies, and ensure patient-centered, regulatory-ready endpoints that support drug development and approvals.