Head of Patient Science, Instrument Development & Thought Leadership
Core
Leads strategic, scientific, and regulatory development of Clinical Outcomes Assessments (COAs) and Composite Measures to incorporate patient perspectives into drug development and commercialization.
Role type
Senior IC Head of Patient Science & Instrument Development
Builds
Validated COA instruments (PROs, ObsROs, ClinROs) for use in clinical trials, real-world studies, and regulatory submissions.
Domain
Healthcare / Clinical Research / Patient-Centered Outcomes Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
COA methodology, psychometrics, FDA/EMA regulatory guidelines, qualitative research methods, strategic planning, team leadership, scientific writing, stakeholder engagement
Preferred skills
Digital Measurement Plans, eCOA strategies, Patient Experience Data (PED) analytics, acquisition science integration
Technologies
eCOA platforms, Digital Measurement Plans, PED analytics tools
Responsibilities
Define instrument development strategies across therapeutic areas; Lead development and validation of new and existing COA instruments; Lead interactions with regulatory bodies (FDA, EMA); Direct use of advanced methodologies including Digital Measurement Plans and eCOA strategies; Mentor and build a team of experienced scientists; Represent the company at scientific conferences and industry consortia
Seniority
Senior, hands-on IC with strategic leadership
