Senior COA Strategy & Instrument Lead

IQVIA Inc; Madrid; On-site; EUR 90,000 - 130,000; Full time

Job summary

IQVIA is seeking an Associate Principal/Principal Clinical Outcome Assessment Endpoint Strategy to provide expert COA endpoint strategy, instrument development, and regulatory guidance for client projects. You will lead science-driven recommendations, mentor teams, and help shape COA solutions across therapeutic areas.

The role emphasizes advancing patient-centered measurement science and contributing to external thought leadership through publications and conferences.

Qualifications

• 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.
• Well-developed written and verbal communication skills including presentations and workshops.

Responsibilities

• Develop COA endpoint strategies across clinical development programs, including primary and key secondary endpoint positioning.
• Lead COA instrument development from concept to validation-ready tools.
• Provide guidance for regulatory interactions with FDA and other authorities.
• Mentor COA consultants and support capability development.
• Contribute to publications, conferences, and external collaborations.

Skills

COA types

COA endpoint strategies

FDA engagement

Mentoring

Scientific writing

Education

Advanced degree (PhD/MD/PharmD/DrPH/MSc)

Job description

IQVIA is seeking an Associate Principal/Principal Clinical Outcome Assessment Endpoint Strategy to provide expert COA endpoint strategy, instrument development, and regulatory guidance for client projects. You will lead science-driven recommendations, mentor teams, and help shape COA solutions across therapeutic areas.

The role emphasizes advancing patient-centered measurement science and contributing to external thought leadership through publications and conferences.