Director, Clinical Development
Core
Develops strategy and plans for Phase 1-3 clinical studies for neurological, neuroendocrine, and neuropsychiatric disorders.
Role type
Director, Clinical Development
Builds
Clinical development programs for biopharmaceutical treatments
Domain
Biopharmaceuticals / Neuroscience
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
clinical trial strategy, protocol development, clinical investigator selection, adverse event assessment, outcome measure selection, regulatory submission strategy, budget planning, team leadership, scientific writing, FDA interaction
Preferred skills
CRO management experience, therapeutic area specialty training, thought leadership
Technologies
ICH-GCP, regulatory filing systems
Responsibilities
Direct Phase 1-3 clinical trials, develop and implement study protocols, select clinical investigators, assess adverse events, lead outcome measure selection, oversee clinical trials program, analyze and present study results, identify resource requirements, recruit and train clinical teams, select clinical consultants, write and review clinical study reports, set regulatory process strategy
Seniority
Director, strategic planning & team leadership
