Medical Director / Associate Medical Director – Neurology

About the role

Thermo Fisher Scientific is seeking an experienced Medical Director or Associate Medical Director to provide medical oversight for neurology clinical trials. You will ensure compliance with company SOPs, client directives, Good Clinical Practice and regulatory requirements while supporting the safety monitoring of investigational drugs.

Key responsibilities

• Oversee medical aspects of clinical trials, ensuring adherence to SOPs, GCP and ICH guidelines.
• Attend and present at investigator and sponsor meetings, offering medical consultation to clients and project teams.
• Review and analyze serious adverse events, ICSR, and periodic safety reports (PBRER, PSUR, DSUR).
• Support the preparation of regulatory deliverables such as labeling reconciliation, CTD modules, REMS, RMP and CSR.
• Ensure delegated pharmacovigilance tasks are executed correctly and provide therapeutic and protocol training.
• Assist in writing and reviewing safety and efficacy documentation, including IND/NDA reports and signal detection reports.

Required profile

• Extensive experience in pharmacovigilance and clinical trial safety monitoring.
• Strong knowledge of ICH guidelines, GCP and regulatory reporting requirements.
• Proven ability to communicate medical information clearly to multidisciplinary teams.
• Experience in neurology therapeutic area is preferred.

Required skills

• ICH guidelines
• Good Clinical Practice (GCP)
• Pharmacovigilance
• Clinical trial safety monitoring
• Regulatory reporting (PBRER, PSUR, DSUR)

What we offer

• Opportunity to work on impactful global health projects.
• Access to Thermo Fisher’s resources for professional development.
• Collaborative environment with leading experts in drug safety.