Medical Director, Clinical Trial Physician - Neurology (Remote) - FSP
Core
Provide medical leadership for clinical trials in autoimmune diseases, ensuring study validity, safety, and regulatory compliance for a global biotech client.
Role type
Senior Clinical Trial Physician (Medical Director)
Builds
Clinical trial protocols, reports, and regulatory submissions for novel autoimmune treatments
Domain
Biotechnology / Clinical Research / Neurology
Deliverable
client delivery
Required skills
Medical leadership, protocol design, medical monitoring, regulatory document interpretation, stakeholder management, GCP compliance, cross-functional collaboration
Preferred skills
Pediatric neurology or neuromuscular disease expertise, NDA submission experience, adverse event reporting knowledge
Technologies
Clinical trial management systems, regulatory submission platforms
Responsibilities
Create and review clinical trial protocols and amendments; conduct real-time medical monitoring for subject safety; interpret clinical data for regulatory documents and publications; serve as medical point of contact for investigators and health authorities; ensure study compliance with SOPs and GCP; harmonize medical decisions across the study team
Seniority
Senior, hands-on IC
