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

pIQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics, and human ingenuity to drive healthcare forward. /ppbThe Patient Centered Solutions team /b b(PCS) /b /ppThe PCS team leads the industry in the science of measuring the patient experience. We pair strategic consulting expertise with technical scientific knowledge to design and execute scientifically rigorous research that incorporates the patient voice into the development and commercialization of new medicines.

This research includes qualitative (e.g., patient interviews, focus groups), quantitative (e.g., clinical outcome assessments (COAs)/patient-reported outcomes (PROs), preference research) and passive (e.g., digital health technology tools) approaches to understand patient, caregiver and physician experiences and expectations of disease and treatment. /ppbWhy join? /b /plipBecome part of a recognized global leader in patient-focused research /p /lilipKeep growing with an organization that encourages and invests in continuous professional and personal development /p /lilipApply your business and leadership skills in an entrepreneurial and multi-disciplinary team /p /lilipContinue challenging yourself by addressing the toughest client issues, working across multiple geographies and solutions in a dynamic and crucial field for the industry /p /lilipMake a difference to patients by enabling

the successful approval or launch of new treatments with features that are truly patient-centric /p /lipbResponsibilities /b /ppThe Associate Principal/ Principal Clinical Outcome Assessment (COA) Endpoint Strategy serves as the subject matter expert for COA endpoint strategy, endpoint development, COA regulatory strategy, and COA instrument science in client engagement and project delivery. This role brings deep expertise in COA measurement science to differentiate client solutions through expert-driven, highly insightful endpoint strategies. The role acts as a trusted advisor to pharmaceutical and biotechnology sponsors and represents IQVIA as an external scientific thought leader while ensuring internal scientific quality and best practices.

Key responsibilities include: /ppbClient Strategy Leadership Scientific Differentiation /b /plipDevelop COA endpoint strategies across clinical development programs, including primary and key secondary endpoint positioning in consulting projects. /p /lilipBring COA expertise into client meetings, workshops, and strategic discussions. /p /lilipDifferentiate proposals and client solutions through expert-driven COA strategy narratives. /p /lilipTranslate emerging scientific and regulatory expectations into actionable client recommendations. /p /lipbRegulatory-Grade Endpoint Strategy FDA Engagement /b /plipAdvise sponsors on development and justification of COA endpoint strategies for regulatory interactions. /p /lilipSupport preparation for and participation in FDA meetings as the COA subject matter expert. /p /lilipGuide sponsors on evidence expectations, context of use, and

fit-for-purpose COA strategies. /p /lipbCOA Instrument Development Leadership /b /plipProvide scientific leadership in the development of new COA instruments from concept to validation-ready tools. /p /lilipLead and advise on drafting and refinement of COA instrument items, response options, recall periods, and scoring approaches. /p /lilipOversee qualitative research activities supporting content validity, including concept elicitation and cognitive interviewing. /p /lilipEnsure new COA instruments are patient-centered, scientifically robust, and fit-for-purpose for clinical and regulatory use. /p /lipbInternal SME Oversight Quality Assurance /b /plipServe as subject matter expert overseeing internal project teams executing COA strategy and development work. /p /lilipReview and approve key scientific deliverables to ensure quality, rigor, and alignment with best practices. /p

/lilipMentor and coach COA consultants, supporting capability development across the organization. /p /lipbBusiness Development Practice Growth /b /plipSupport business development through proposal leadership, solution design, and client presentations. /p /lilipContribute to the evolution of COA strategy methodologies, frameworks, and reusable assets. /p /lipbExternal Scientific Leadership Visibility /b /plipMaintain a strong external profile through publications, conference presentations, and scientific collaborations. /p /lilipRepresent IQVIA as a recognized expert in COA science and endpoint strategy. /p /lilipContribute to academic teaching, advisory boards, or industry working groups where appropriate. /p /lipbEssential experience, skills and education required /b /plipDeep expertise across COA types (PRO, ObsRO, ClinRO, PerfO) and their application in clinical research. /p

/lilipExtensive experience developing COA endpoint strategies across multiple therapeutic areas. /p /lilipHands-on experience developing new COA instruments, including item writing and qualitative validation. /p /lilipExperience supporting FDA-facing endpoint strategy and regulatory interactions. /p /lilipAbility to mentor junior team members. /p /lilipExcellent scientific writing, presentation, and stakeholder engagement skills. /p /lilipAdvanced degree (PhD, MD, PharmD, DrPH, MSc) in a relevant scientific discipline strongly preferred. /p /lilipStrong publication record and recognized credibility in outcomes research or COA measurement science. /p /lilipWell-developed written and verbal communication skills including presentations, chairing meetings, external conference presentations, workshop facilitation, business and report writing. /p /lilipAn entrepreneurial nature and interest in

developing new client offerings and solutions and in building the capability to deliver the same. /p /lipIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at /ppIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete.

Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. /p