Director, Clinical Operations
Core
Lead operational execution of early-stage clinical development programs for Alzheimer's disease, translating scientific strategy into high-quality studies.
Role type
Director, Clinical Operations
Builds
Early clinical studies (older adults to early Alzheimer's population) integrating clinical pharmacology, PK/PD, biomarkers, and functional assessments.
Domain
Biotechnology / Alzheimer's disease / CNS / Clinical Pharmacology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical program ownership, early-stage CNS development, clinical pharmacology, PK/PD studies, biomarker-intensive trials, IND/CTA preparation, CRO/vendor management, study logistics, risk management
Preferred skills
Experience with older adults/cognitively impaired participants, population PK, model-informed drug development, regulatory authority interactions
Technologies
Clinical trial management systems, bioanalytical laboratories, central labs
Responsibilities
Own operational delivery from protocol development to close-out; Lead execution of randomized/crossover studies; Partner with Clinical Development, Pharmacology, Biostatistics, Regulatory, and CMC; Manage CROs, clinical units, and specialty vendors; Ensure GCP compliance and inspection-ready documentation; Develop recruitment/retention strategies; Build scalable clinical operations infrastructure
Seniority
Director, hands-on IC with leadership responsibilities
