Medical Director/Sr Medical Director - Neurology(Remote U.S)
Core
Provide medical oversight of clinical trials and marketed products for top pharmaceutical companies and biotechs, ensuring compliance with GCP and regulatory requirements while managing safety data and signal detection.
Role type
Senior Individual Contributor Medical Director (Neurology)
Builds
Clinical trial deliverables (CSRs, safety reports, CTD modules) and marketed product safety dossiers
Domain
Life Sciences / Clinical Research / Pharmacovigilance
Required skills
Medical licensure, Therapeutic expertise in Neurology, Clinical trial management, Pharmacovigilance, Safety data analysis, Regulatory compliance (FDA/ICH/EMA/GCP), Medical writing, Signal detection
Preferred skills
Active medical licensure, Neurology Residency/Fellowship, Experience as Principal Investigator, Mentorship
Technologies
Medra, Safety databases
Responsibilities
Monitor safety variables (AEs, lab abnormalities) and review adverse events; Provide medical consultation to investigators and clients; Review and write clinical study reports and safety periodic reports; Manage signal detection activities and support label updates; Ensure adherence to client SOPs and regulatory guidelines.
Seniority
Senior, hands-on IC