Description
IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.
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.
Responsibilities:
- Define instrument development strategies across therapeutic areas, ensuring alignment with Instrument Licensing & Services, R&DS Therapeutic Area Priorities and R&DS goals, FDA/EMA guidance on patient-focused drug development (PFDD), and HTA requirements.
- Lead the development, validation, and implementation of new and existing COA instruments, including psychometric evaluation, qualitative research, and endpoint definition.
- Lead interactions with regulatory bodies (FDA, EMA) regarding newly developed COAs designed to replace older declining in relevance COAs.
- Direct the use of advanced methodologies, with a heavy focus on Domains of Health, including Digital Measurement Plans, eCOA (electronic COA) strategies, and Patient Experience Data (PED) analytics.
- Partner with Instrument Licensing & Services (IQVIA Quality Metric), Strategic & Scientific Research, R&DS Design & Delivery Innovation including the TSSU/Therapeutic Area COE, clinical operations, biometrics, regulatory, and commercial teams build, expand and enhance COA utility in measuring meaningful change in health.
- Mentor and build a team of experienced and burgeoning scientists, guiding them in COA methodologies and scientific best practices.
- Act as a recognized expert in the field, representing the company at scientific conferences (e.g., ISPOR, ISOQOL, CPATH, etc) 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 of professional experience in COA/outcomes research within pharmaceutical, CRO, or consultancy settings, with a strong track record of publications.
- 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 communicate complex data to regulatory bodies and internal senior leadership.
- Influencing & Relationship Development: Proven influencing skills at the senior management level, have the presence and credibility to engage and influence senior leaders across multi-geographies and functions.
- Leadership: Proven experience in managing high-performing teams, building talent, and influencing cross-functional stakeholders.