COA Strategy & Instrument Lead

IQVIA Holdings Inc.; City of Westminster; Vor Ort; GBP 120.000 - 170.000; Vollzeit

Zusammenfassung

IQVIA is seeking an Associate Principal/Principal COA Endpoint Strategy to lead COA measurement science across clinical development, shaping endpoint strategies and instrument design for diverse therapeutic areas.

You will partner with pharmaceutical sponsors, translate regulatory expectations into actionable recommendations, mentor junior staff, and publish externally, while contributing to internal quality and capability development.

Qualifikationen

• 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.
• An entrepreneurial nature and interest in developing new client offerings and solutions.

Aufgaben

• Lead COA endpoint strategy across clinical development programs and primary/key secondary endpoint positioning.
• Bring COA expertise into client meetings, workshops, and strategic discussions.
• Differentiate proposals and client solutions through expert-driven COA strategy narratives.
• Translate emerging scientific and regulatory expectations into actionable client recommendations.
• Provide scientific leadership in development of COA instruments from concept to validation-ready tools.
• Lead and advise on drafting and refinement of COA instrument items, response options, recall periods, and scoring approaches.
• Oversee qualitative research activities supporting content validity (concept elicitation, cognitive interviewing).
• Ensure new COA instruments are patient-centered, scientifically robust, and fit-for-purpose for clinical and regulatory use.
• Serve as SME overseeing internal project teams and quality of deliverables.
• Mentor COA consultants and support capability development.
• Support business development through proposal leadership and client presentations.
• Contribute to evolution of COA strategy methodologies and reusable assets.
• Maintain external profile via publications, conferences, and collaborations.
• Represent IQVIA as a recognized COA science expert.

Jobbeschreibung

IQVIA is seeking an Associate Principal/Principal COA Endpoint Strategy to lead COA measurement science across clinical development, shaping endpoint strategies and instrument design for diverse therapeutic areas.

You will partner with pharmaceutical sponsors, translate regulatory expectations into actionable recommendations, mentor junior staff, and publish externally, while contributing to internal quality and capability development.