Medical Director/Sr Medical Director - Neurology(Remote U.S)
Core
Provide medical oversight of clinical trials and marketed products for top pharmaceutical and biotech clients, ensuring adherence to GCP, regulatory requirements, and client directives.
Role type
Senior Individual Contributor Medical Director (Neurology)
Builds
Clinical trial deliverables (CSRs, safety reports, CTD modules) and marketed product safety dossiers/labels
Domain
Life Sciences / Clinical Research / Pharmacovigilance
Deliverable
client delivery
Required skills
Medical judgment, safety data analysis, protocol interpretation, regulatory compliance (FDA/ICH/EMA/GCP), therapeutic expertise in Neurology, signal detection, aggregate report review
Preferred skills
Active medical licensure, experience as Principal Investigator, biostatistics knowledge, mentoring capabilities
Technologies
Medra, safety databases
Responsibilities
Monitor safety variables (AEs, lab abnormalities) and review adverse event data; Provide medical consultation to investigators and clients on study-related questions; Review and interpret safety/efficacy data for CSR, IND/NDA, and periodic safety reports; Manage signal detection activities and support label updates and risk management; Ensure proper execution of delegated tasks and adherence to client SOPs
Seniority
Senior, hands-on IC with mentorship responsibilities