Head of Patient Science, Instrument Development & Thought Leadership
Core
Lead the strategic, scientific, and regulatory development of Clinical Outcomes Assessments (COAs) and Composite Measures for BioPharmaceutical and Medical Device organizations.
Role type
Senior IC patient science and instrument development leader
Builds
Clinical Outcomes Assessments (COAs), Composite Measures, and thought leadership assets (white papers, manuscripts)
Domain
Healthcare / Clinical Research / Patient-Reported Outcomes (PROs)
Required skills
COA methodology, psychometrics, FDA/EMA regulatory guidelines, qualitative research methods, strategic leadership, team mentorship, scientific writing, stakeholder influence
Preferred skills
Advanced degree in Psychology/Health Services Research, 10+ years in outcomes research, publication record, experience with eCOA strategies
Technologies
eCOA, Digital Measurement Plans, Patient Experience Data (PED) analytics
Responsibilities
Define instrument development strategies across therapeutic areas; Lead development and validation of new COA instruments; Lead interactions with regulatory bodies (FDA, EMA); Direct use of advanced methodologies including Digital Measurement Plans; Mentor and build a team of scientists; Represent the company at scientific conferences
Seniority
Senior, hands-on IC with strategic leadership