Global Scientific Lead - Clinical Outcome Assessment (COA) Strategy Consulting - Multiple locat[...]

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ph3Global Scientific Lead - Clinical Outcome Assessment (COA) Strategy Consulting - Multiple locations - Hybrid/Home-based /h3pbResponsibilities /b /ppThe Global Scientific Lead for Clinical Outcome Assessment (COA) Endpoint Strategy serves as the senior scientific authority in the COA Consulting team within Patient Centered Solutions.

This role brings deep expertise in COA measurement science and Patient Experience Data (PED) more broadly , to differentiate client solutions through expert‑driven, highly insightful endpoint and PED strategies. /ppbPeople and organizational leadership /b /ppServe as the global scientific lead for consulting activities, providing strategic oversight and leadership across the PCS consulting organization. /ppLead and develop talent through a combination of direct line management, broader mentoring, and active cultivation of scientific capabilities across the consulting team. /ppChampion excellence in scientific outputs, driving consistency, quality, and innovation in clinical outcome assessment (COA) and PED‑related deliverables. /ppSet and shape the long‑term vision and strategy for scientific activities within consulting, working in close partnership with senior leadership. /ppbClient Strategy Leadership Scientific Differentiation /b /ppDevelop COA endpoint and PED strategies across clinical development programs, including primary and key secondary endpoint positioning in consulting projects. /ppBring senior COA and PED expertise into client meetings, workshops, and strategic discussions. /ppDifferentiate proposals and client solutions through expert‑driven COA and PED strategy narratives. /ppTranslate emerging scientific and regulatory expectations into actionable client recommendations. /ppbRegulatory‑Grade Endpoint Strategy FDA Engagement /b /ppAdvise sponsors on development and justification of COA endpoint strategies for regulatory interactions. /ppSupport preparation for and participation in FDA meetings as the COA subject matter expert. /ppGuide sponsors on evidence expectations, context of use, and fit‑for‑purpose COA strategies. /ppProvide senior scientific leadership in the development of new COA instruments from concept to validation‑ready tools. /ppLead and advise on drafting and refinement of COA instrument items, response options, recall periods, and scoring approaches. /ppOversee qualitative research activities supporting content validity, including concept elicitation and cognitive interviewing. /ppEnsure new COA instruments are patient‑centered, scientifically robust, and fit‑for‑purpose for clinical and regulatory use. /ppbInternal SME Oversight Quality Assurance /b /ppServe as subject matter expert overseeing internal project teams executing COA and PED strategy and development work. /ppReview and approve key scientific deliverables to ensure quality, rigor, and alignment with best practices. /ppMentor and coach COA and PED scientists and consultants, supporting capability development across the organization. /ppbBusiness Development Practice Growth /b /ppSupport business development through proposal leadership, solution design, and client presentations. /ppContribute to the evolution of COA strategy and PED methodologies, frameworks, and reusable assets. /ppbExternal Scientific Leadership Visibility /b /ppMaintain a strong external profile through publications, conference presentations, and scientific collaborations. /ppRepresent IQVIA as a recognized expert in COA science and endpoint strategy. /ppContribute to academic teaching, advisory boards, or industry working groups where appropriate. /ph3Essential experience, skills and education required /h3ulliDeep expertise across COA types (PRO, ObsRO, ClinRO, PerfO) and their application in clinical research. /liliExtensive experience developing COA endpoint strategies across multiple therapeutic areas. /liliHands‑on experience developing new COA instruments, including item writing and qualitative validation. /liliStrong experience supporting FDA‑facing endpoint strategy and regulatory interactions. /liliBroad experience across PED methodologies and application of PED by regulators, payers and other stakeholders desirable. /liliProven ability to lead, mentor, and oversee multidisciplinary scientific teams. /liliExcellent scientific writing, presentation, and stakeholder engagement skills. /liliAdvanced degree (PhD, MD, PharmD, DrPH, MSc) in a relevant scientific discipline strongly preferred. /liliStrong publication record and recognized credibility in outcomes research or COA measurement science. /liliWell‑developed written and verbal communication skills including presentations, chairing meetings, external conference presentations, workshop facilitation, business and report writing. /liliAn entrepreneurial nature and interest in developing new client offerings and solutions and in building the capability to deliver the same. /li /ul /p #J-18808-Ljbffr