Medical Director / Senior Medical Director, Neurology

About the role

Thermo Fisher Scientific is seeking an experienced Medical Director or Senior Medical Director to lead neurology clinical trials. The role provides medical oversight across all phases of drug development, ensuring compliance with company SOPs, client directives, Good Clinical Practice, and regulatory requirements.

Key responsibilities

• Provide medical oversight of clinical trials, ensuring adherence to SOPs, GCP, and regulatory standards.
• Attend and present at investigator and sponsor meetings, offering medical consultation to clients, investigators, and project teams.
• Support business development activities and conduct medical review and analysis of serious adverse events.
• Supervise medical monitors, ensuring delegated tasks are executed correctly.
• Deliver therapeutic and protocol training on assigned studies.
• Assist in the preparation and review of clinical study reports, IND/NDA submissions, ICSR, signal detection reports, periodic safety updates, RMP, REMS, and CTD modules.
• Monitor safety variables (adverse events, laboratory abnormalities, patient status changes) and manage un‑blinding requests.
• Communicate medical concerns with principal investigators and clients, applying sound medical judgment.

Required profile

• Medical degree (MD or equivalent) with extensive experience in clinical trial safety oversight.
• Deep knowledge of ICH guidelines, GCP, and regulatory requirements for drug development.
• Proven ability to lead cross‑functional teams and provide clear medical guidance.
• Strong written and verbal communication skills for interaction with investigators, sponsors, and internal stakeholders.

Required skills

• Medical oversight of clinical trials.
• Clinical safety monitoring and adverse event management.
• Medical writing for CSR, IND/NDA, ICSR, RMP, REMS, and CTD documents.
• Therapeutic and protocol training delivery.