Head of Patient Science, Instrument Development & Thought Leadership
Overview
IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. The Instrument Development and Thought Leadership segment develops new clinical outcome instruments, expands and enhances existing instruments, with a focus on priority therapeutic areas. Thought leadership includes white papers, manuscripts/publications, podium presentations; posters and books. Coordination with the PACT team, clients, industry thought leaders, regulators, patient advocacy groups and other stakeholders is a critical component of our work.
The Role
The Head of Patient and Instrument Science and Thought Leadership leads the strategic, scientific and regulatory development of Clinical Outcomes Assessments (COAs) and Composite Measures. COAs include patient-centered research patient-reported outcomes (PROs), observer-reported outcomes (ObsROs), and clinician-reported outcomes (ClinROs). These instruments are used in clinical trials, real-world studies and in day-to-day clinical practice. The individual is responsible for ensuring that the patient perspective is rigorously measured and incorporated into drug development, measurement endpoint strategy, regulatory submissions, and commercialization using behavioral and measurement science.
Responsibilities
- Strategic Leadership: Define instrument development strategies across therapeutic areas, ensuring alignment with Instrument Licensing & Services, R&D Therapeutic Area Priorities and R&D goals, FDA/EMA guidance on patient-focused drug development (PFDD), and HTA requirements.
- Scientific Excellence: Lead the development, validation, and implementation of new and existing COA instruments, including psychometric evaluation, qualitative research, and endpoint definition.
- Regulatory Engagement: Lead interactions with regulatory bodies (FDA, EMA) regarding newly developed COAs designed to replace older, declining-in-relevance COAs.
- Methodological Expertise: Direct the use of advanced methodologies, with a focus on Domains of Health, including Digital Measurement Plans, eCOA (electronic COA) strategies, and Patient Experience Data (PED) analytics.
- Cross-functional Collaboration: Partner with Instrument Licensing & Services (IQVIA Quality Metric), Strategic & Scientific Research, R&D Design & Delivery Innovation including the TSSU/Therapeutic Area COE, clinical operations, biometrics, regulatory, and commercial teams to build, expand and enhance COA utility in measuring meaningful health change.
- Team Leadership: Mentor and build a team of scientists, guiding them in COA methodologies and scientific best practices; participate in acquisition science and staff integration as relates to COA assets and scientific SMEs.
- External Representation: Represent the company at scientific conferences (e.g., ISPOR, ISOQOL, CPATH) and in industry consortia.
Required Qualifications & Skills
- Education: Advanced degree (PhD, Master’s, or equivalent) in Psychology, Behavioral measurement, Health Services Research, Epidemiology, Pharmacy, Public Health, or a related discipline.
- Experience: 10+ years in COA/outcomes research within pharmaceutical, CRO, or consultancy settings, with a strong publication record.
- Technical Knowledge: Deep understanding of COA methodology, psychometrics, FDA/EMA regulatory guidelines on patient-focused drug development, and qualitative research methods.
- Communication: Excellent scientific writing and verbal skills, with the ability to convey complex data to regulatory bodies and internal senior leadership.
- Influencing & Relationship Development: Proven ability to influence senior leaders across geographies and functions, with a track record of building broad stakeholder relationships.
- Leadership: Experience managing high-performing teams, building talent, and effectively managing change in a fast-paced environment.
We invite you to join IQVIA. Please submit your CV in English. IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information submitted in your application must be truthful and complete. This description reflects the responsibilities and qualifications for the role as described by IQVIA and may be updated.
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