Medical Director – Integrated Phase I‑IV Clinical Trials

About the role

Thermo Fisher Scientific is seeking a Medical Director to lead medical oversight of its Integrated Phase I‑IV clinic. You will ensure that clinical trials are conducted in compliance with company SOPs, sponsor directives, Good Clinical Practice (GCP) and all applicable regulatory requirements, while contributing to the development of life‑changing therapies.

Key responsibilities

• Provide medical oversight for Phase I‑IV clinical studies, ensuring protocol compliance, data integrity and patient safety.
• Review and analyze serious adverse events, ICSR, and periodic safety reports (PBRER, PSUR, DSUR) and support preparation of regulatory deliverables such as labeling reconciliation, CTD modules, REMS, RMP and CSR.
• Attend and present at investigator and sponsor meetings, offering medical consultation to clients, investigators and project teams.
• Lead and mentor Principal Investigators and Sub‑Investigators, managing performance, development and professional growth.
• Partner with operational and clinical teams to meet enrolment, retention, database quality and timeline milestones.
• Act as senior medical authority for risk management, inspection readiness, audit responses and continuous quality improvement.

Required profile

• Medical degree with extensive experience in clinical research and drug development.
• Proven track record of overseeing Phase I‑IV trials and managing safety reporting.
• Strong understanding of regulatory requirements, ethics committee approvals and GCP standards.
• Excellent leadership, communication and stakeholder‑management skills.

Required skills

• Good Clinical Practice (GCP)