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

Location: Reading, Berkshire, United Kingdom

Company

IQVIA provides clinical research services, commercial insights, and healthcare intelligence for life sciences and healthcare organizations.

What you will do

• Develop COA endpoint strategies across clinical development programs, including primary and key secondary endpoint positioning.
• Advise pharmaceutical and biotechnology sponsors on COA evidence, context of use, fit-for-purpose strategies, and regulatory interactions.
• Support FDA meetings as the COA subject matter expert and translate emerging scientific and regulatory expectations into recommendations.
• Lead the development of COA instruments, including item writing, response options, recall periods, scoring approaches, concept elicitation, and cognitive interviewing.
• Review scientific deliverables, oversee internal project teams, and mentor COA consultants.
• Lead proposals and client presentations while contributing to methodologies, publications, conferences, and external scientific collaborations.

Requirements

• Deep expertise in PRO, ObsRO, ClinRO, and PerfO measures and their use in clinical research.
• Extensive experience developing COA endpoint strategies across multiple therapeutic areas.
• Hands-on experience developing COA instruments, including item writing and qualitative validation.
• Experience supporting FDA-facing endpoint strategy and regulatory interactions.
• Strong scientific writing, presentation, stakeholder engagement, meeting facilitation, and mentoring skills.
• An advanced degree such as PhD, MD, PharmD, DrPH, or MSc in a relevant scientific discipline is strongly preferred, along with a strong publication record.

Culture & Benefits

• Work within a multidisciplinary Patient Centered Solutions team focused on measuring patient experiences.
• Contribute to research combining qualitative, quantitative, and passive approaches to understand patient, caregiver, and physician experiences.
• Access continuous professional and personal development opportunities.
• Address complex client issues across multiple geographies and healthcare solutions.
• Contribute to patient-centered treatment development and commercialization.