Global Scientific Lead for Clinical Outcome Assessment (COA) Endpoint Strategy
People and Organizational Leadership
Serve as the global scientific lead for consulting activities, providing strategic oversight and leadership across the PCS consulting organisation. Lead and develop talent through a combination of direct line management, broader mentoring, and active cultivation of scientific capabilities across the consulting team. Champion excellence in scientific outputs, driving consistency, quality, and innovation in clinical outcome assessment (COA) and PED‑related deliverables. Set and shape the long‑term vision and strategy for scientific activities within consulting, working in close partnership with senior leadership. Client Strategy Leadership & Scientific Differentiation
Develop COA endpoint and PED strategies across clinical development programs, including primary and key secondary endpoint positioning in consulting projects. Bring senior COA and PED expertise into client meetings, workshops, and strategic discussions. Differentiate proposals and client solutions through expert‑driven COA and PED strategy narratives. Translate emerging scientific and regulatory expectations into actionable client recommendations. Regulatory–Grade Endpoint Strategy & FDA Engagement
Advise sponsors on development and justification of COA endpoint strategies for regulatory interactions. Support preparation for and participation in FDA meetings as the COA subject matter expert. Guide sponsors on evidence expectations, context of use, and fit‑for‑purpose COA strategies. COA Instrument Development Leadership
Provide senior scientific leadership in the development of new 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, including concept elicitation and cognitive interviewing. Ensure new COA instruments are patient‑centered, scientifically robust, and fit‑for‑purpose for clinical and regulatory use. Internal SME Oversight & Quality Assurance
Serve as subject matter expert overseeing internal project teams executing COA and PED strategy and development work. Review and approve key scientific deliverables to ensure quality, rigor, and alignment with best practices. Mentor and coach COA and PED scientists and consultants, supporting capability development across the organization. Business Development & Practice Growth
Support business development through proposal leadership, solution design, and client presentations. Contribute to the evolution of COA strategy and PED methodologies, frameworks, and reusable assets. External Scientific Leadership & Visibility
Maintain a strong external profile through publications, conference presentations, and scientific collaborations. Represent IQVIA as a recognized expert in COA science and endpoint strategy. Contribute to academic teaching, advisory boards, or industry working groups where appropriate. Essential Experience, Skills and Education
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. Strong experience supporting FDA‑facing endpoint strategy and regulatory interactions. Broad experience across PED methodologies and application of PED by regulators, payers and other stakeholders desirable. Proven ability to lead, mentor, and oversee multidisciplinary scientific teams. Excellent scientific writing, presentation, and stakeholder engagement skills. Advanced degree (PhD, MD, PharmD, DrPH, MSc) in a relevant scientific discipline strongly preferred. Strong publication record and recognized credibility in outcomes research or COA measurement science. Well‑developed written and verbal communication skills, including presentations, chairing meetings, external conference presentations, workshop facilitation, business and report writing. An entrepreneurial nature and interest in developing new client offerings and solutions and in building the capability to deliver the same.
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People and Organizational Leadership
Serve as the global scientific lead for consulting activities, providing strategic oversight and leadership across the PCS consulting organisation. Lead and develop talent through a combination of direct line management, broader mentoring, and active cultivation of scientific capabilities across the consulting team. Champion excellence in scientific outputs, driving consistency, quality, and innovation in clinical outcome assessment (COA) and PED‑related deliverables. Set and shape the long‑term vision and strategy for scientific activities within consulting, working in close partnership with senior leadership. Client Strategy Leadership & Scientific Differentiation
Develop COA endpoint and PED strategies across clinical development programs, including primary and key secondary endpoint positioning in consulting projects. Bring senior COA and PED expertise into client meetings, workshops, and strategic discussions. Differentiate proposals and client solutions through expert‑driven COA and PED strategy narratives. Translate emerging scientific and regulatory expectations into actionable client recommendations. Regulatory–Grade Endpoint Strategy & FDA Engagement
Advise sponsors on development and justification of COA endpoint strategies for regulatory interactions. Support preparation for and participation in FDA meetings as the COA subject matter expert. Guide sponsors on evidence expectations, context of use, and fit‑for‑purpose COA strategies. COA Instrument Development Leadership
Provide senior scientific leadership in the development of new 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, including concept elicitation and cognitive interviewing. Ensure new COA instruments are patient‑centered, scientifically robust, and fit‑for‑purpose for clinical and regulatory use. Internal SME Oversight & Quality Assurance
Serve as subject matter expert overseeing internal project teams executing COA and PED strategy and development work. Review and approve key scientific deliverables to ensure quality, rigor, and alignment with best practices. Mentor and coach COA and PED scientists and consultants, supporting capability development across the organization. Business Development & Practice Growth
Support business development through proposal leadership, solution design, and client presentations. Contribute to the evolution of COA strategy and PED methodologies, frameworks, and reusable assets. External Scientific Leadership & Visibility
Maintain a strong external profile through publications, conference presentations, and scientific collaborations. Represent IQVIA as a recognized expert in COA science and endpoint strategy. Contribute to academic teaching, advisory boards, or industry working groups where appropriate. Essential Experience, Skills and Education
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. Strong experience supporting FDA‑facing endpoint strategy and regulatory interactions. Broad experience across PED methodologies and application of PED by regulators, payers and other stakeholders desirable. Proven ability to lead, mentor, and oversee multidisciplinary scientific teams. Excellent scientific writing, presentation, and stakeholder engagement skills. Advanced degree (PhD, MD, PharmD, DrPH, MSc) in a relevant scientific discipline strongly preferred. Strong publication record and recognized credibility in outcomes research or COA measurement science. Well‑developed written and verbal communication skills, including presentations, chairing meetings, external conference presentations, workshop facilitation, business and report writing. An entrepreneurial nature and interest in developing new client offerings and solutions and in building the capability to deliver the same.
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Global Scientific Lead - Clinical Outcome Assessment (COA) Strategy Consulting - Multiple locat[...] Arbeitgeber: IQVIA LLC
Als Portfolio Spezialist im Bereich Diabetes & Adipositas bieten wir Ihnen die Möglichkeit, in einem dynamischen und innovativen Umfeld zu arbeiten, das auf nachhaltige Kundenbeziehungen und den wirtschaftlichen Erfolg unserer Produkte fokussiert ist. Unsere Unternehmenskultur fördert kontinuierliche Weiterbildung und persönliche Entwicklung, während attraktive Benefits wie ein unbefristetes Arbeitsverhältnis, ein top ausgestatteter Firmenwagen zur privaten Nutzung und vielfältige Corporate Benefits Ihre Work-Life-Balance unterstützen. In der Region Büdingen, Fulda, Gelnhausen und Schlüchtern profitieren Sie von einer hohen Übernahmequote durch unsere Kunden, was Ihnen einen vielversprechenden Karrierestart in der Pharmabranche ermöglicht.
