Medical Director, Clinical Research Neurology
Core
Design and execute clinical development plans for neurology assets, serving as the Clinical Research Lead for programs in the CNS therapeutic area.
Role type
Senior Medical Director (Clinical Research, Neurology)
Builds
Clinical development programs for novel therapies in neurology
Domain
Pharmaceuticals, Clinical Research, Neurology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study design, global clinical trial leadership, regulatory submission strategy, KOL network development, safety monitoring oversight, statistical analysis plan review, clinical report writing, FDA/GCP/ICH regulation expertise
Preferred skills
Pediatrics experience, regenerative cell medicine/gene therapy background, Japan organization experience
Technologies
eCRF design, database design tools, data collection systems
Responsibilities
Lead clinical development programs and study design from concept to protocol; oversee clinical trial conduct with CROs and medical monitors; serve as internal medical monitor and provide input on statistical analysis plans and clinical study reports; contribute to regulatory filings (BLA/NDAs) and health authority responses; develop KOL networks and coordinate Scientific Advisory Boards; review clinical data and interpret findings.
Seniority
Senior, hands-on IC with leadership responsibilities
