Medical Director / Senior Medical Director – Rheumatology

About the role

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

Key responsibilities

• Oversee clinical trial conduct, ensuring adherence to SOPs, client directives, GCP and ICH guidelines.
• Present at investigator and sponsor meetings, offering medical consultation to clients, investigators and project teams.
• Review and analyze serious adverse events, ICSR, periodic safety reports (PBRER, PSUR, DSUR) and other regulatory deliverables.
• Provide therapeutic and protocol training, and assist in the preparation of CSR, IND/NDA reports, labeling reconciliation, REMS, RMP and CTD modules.
• Monitor safety variables (AE, lab abnormalities, concomitant medications) and communicate medical concerns to principal investigators and clients.

Required profile

• Medical degree with extensive experience in rheumatology and clinical trial oversight.
• Strong knowledge of pharmacovigilance processes and regulatory reporting requirements.
• Proven ability to interpret safety and efficacy data and to communicate findings clearly.
• Experience working with multinational teams and supporting business development activities.

Required skills

• Good Clinical Practice (GCP)
• ICH guidelines
• Pharmacovigilance
• Adverse Event monitoring
• ICSR preparation
• PBRER, PSUR, DSUR reporting
• CTD module preparation
• REMS and RMP management
• CSR authoring