Medical Director / Senior Medical Director – Dermatology

About the role

Thermo Fisher Scientific is seeking an experienced Medical Director (or Senior Medical Director) specialized in Dermatology to provide medical oversight for global clinical trials. You will ensure compliance with SOPs, client directives, Good Clinical Practice, and regulatory requirements while supporting business development and client interactions.

Key responsibilities

• Lead medical review and analysis of serious adverse events, ICSR, and periodic safety reports (PBRER, PSUR, DSUR).
• Prepare and review regulatory deliverables such as labeling reconciliation, CTD modules, REMS, RMP, and CSR documents.
• Provide medical consultation to investigators, sponsors, and internal project teams.
• Monitor safety variables across studies, including adverse events, lab abnormalities, and concomitant medication use.
• Present at investigator and sponsor meetings and contribute to therapeutic and protocol training.
• Support writing and interpretation of safety and efficacy data for IND/NDA submissions and signal detection reports.

Required profile

• Medical degree with board certification or equivalent experience in Dermatology.
• Extensive experience in clinical trial oversight and pharmacovigilance.
• Strong knowledge of ICH guidelines, GCP, and regulatory requirements for global studies.
• Proven ability to communicate complex medical information clearly to diverse stakeholders.

Required skills

• Medical oversight of clinical trials.
• Pharmacovigilance and safety reporting (ICSR, PBRER, PSUR, DSUR).
• Regulatory document preparation (CTD modules, REMS, RMP, CSR).
• Therapeutic and protocol training delivery.