Medical Director, Clinical Research Neurology
Core
Lead clinical development programs and study design for neurology assets, serving as the Clinical Research Lead and internal medical monitor.
Role type
Senior Medical Director, Clinical Research (Neurology)
Builds
Clinical development plans, protocols, regulatory filings (BLA/NDAs), and clinical study reports for neurology therapeutics.
Domain
Pharmaceutical R&D, Neurology, CNS
Required skills
Clinical study design, global clinical trial leadership, regulatory submission strategy, KOL network development, safety monitoring, statistical analysis plan review, clinical data interpretation, regulatory document preparation.
Preferred skills
Pediatrics experience, regenerative cell medicine/gene therapy experience, experience with Japan organizations.
Technologies
eCRF, database design tools, statistical analysis software.
Responsibilities
Lead critical workstreams for clinical development programs; design study protocols from concept to execution; oversee clinical trial conduct with CROs and vendors; serve as internal medical monitor; collaborate with Pharmacovigilance on safety; contribute to regulatory filings and clinical study reports; develop KOL networks and coordinate SABs.
Seniority
Senior, hands-on IC with leadership responsibilities