Director Clinical Outcomes Assessment

Role: Lead the development and execution of Clinical Outcomes Assessment (COA) strategies for neuroscience and rare disease development programs, ensuring patient, caregiver, and clinician perspectives are accurately captured to support regulatory and commercial objectives. Responsibilities: provide scientific leadership on PROs, ClinROs, ObsROs, and PerfOs; ensure outcome measures are fit-for-purpose and aligned with regulatory, HTA, and stakeholder requirements; support interactions with FDA, EMA, and health authorities; contribute to regulatory documents, publications, and conferences; foster external collaborations; monitor evolving measurement methodologies; bridge US and global teams for alignment. Requirements: PhD/PharmD/MD with 8+ years in COA, patient-centered outcomes, or related pharma/biotech fields; 5+ years supporting regulatory interactions; strong communication and collaboration skills; experience operating globally. Preferred: neuroscience or rare disease experience, digital endpoints, innovative measurement tech, regulatory submission contributions. HighValue: neuroscience, rare disease, patient-centered outcomes, regulatory engagement, global collaboration, digital measurement technologies, international travel (~4-6 trips/year). WorkSetup: based in the US, travel as specified.