Global Scientific Lead - Clinical Outcome Assessment (COA) Strategy Consulting - Multiple locations - Hybrid/Home-based
Core
Senior scientific authority leading Clinical Outcome Assessment (COA) and Patient Experience Data (PED) strategies for pharmaceutical and biotechnology sponsors, acting as a trusted advisor and external thought leader.
Role type
Senior IC Clinical Science Lead (COA Strategy)
Builds
Expert-driven COA endpoint strategies, new COA instruments, and regulatory-grade evidence packages for clinical development programs.
Domain
Life Sciences / Clinical Research / Patient-Centered Outcomes
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
COA measurement science expertise, FDA regulatory interaction experience, COA instrument development (item writing, validation), strategic consulting leadership, multidisciplinary team management, scientific writing and presentation
Preferred skills
PED methodologies knowledge, therapeutic area expertise across multiple domains, strong publication record, academic teaching experience
Technologies
Qualitative research tools, cognitive interviewing frameworks, regulatory submission platforms
Responsibilities
Lead and develop talent through direct management and mentoring; Develop COA endpoint strategies for clinical development programs; Advise sponsors on FDA meetings and evidence expectations; Provide scientific leadership in developing new COA instruments; Oversee internal project teams and approve key scientific deliverables; Support business development through proposal leadership and client presentations.
Seniority
Senior, hands-on IC with organizational leadership
