About this role
About the Role 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 by BioPharmaceutical and Medical Device organizations in clinical trials and real-world studies and by Health Care Physicians in day-to-day clinical practice. This 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. What You'll Do
- Strategic Leadership: 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.
- Scientific Excellence: Lead the development, validation, and implementation of new and existing COA instruments, including psychometric evaluation, qualitative research, and endpoint definition. Support the Scientific & Strategic Research Consulting team in their client facing COA endpoint strategy projects as needed.
- 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 heavy focus on Domains of Health, i