Director, Clinical Operations

Role: Lead clinical operations for early-stage Alzheimer’s disease studies, translating scientific strategies into high-quality, efficient trials. Responsibilities: oversee end-to-end study execution from protocol development to close-out, partner with cross-functional teams (clinical development, pharmacology, biostatistics, regulatory), manage CROs/vendors, ensure compliance with GCP and regulatory standards, develop operational plans, and optimize study logistics and participant engagement. Requirements: extensive experience in CNS clinical development, particularly Alzheimer’s or neurodegenerative conditions; strong background in clinical pharmacology, biomarker-driven trials, and studies involving older or cognitively impaired adults; prior support of IND/CTA filings; proven leadership in sponsor-driven clinical operations; familiarity with PK/PD, model-informed drug development, and regulatory interactions. High-Value Details: early-phase Alzheimer’s program, biomarker integration, complex randomized/crossover designs, vendor management, and building scalable clinical processes. Work Setup: likely hybrid or onsite given the complexity and stakeholder collaboration, with an emphasis on fast-paced, high-ownership environment.