Medical Director, Oncology

About the role

The Medical Director, Oncology will lead medical monitoring for global oncology clinical trials at Caidya, a mid‑sized CRO. Based in Italy (remote), you will ensure patient safety, data integrity and regulatory compliance while supporting the development of innovative cancer therapies.

Key responsibilities

• Provide medical and safety oversight of oncology clinical trials in accordance with GCP, SOPs and regulatory requirements.
• Develop, review and update the Medical Monitoring Plan and Safety Management Plan.
• Offer medical consultation to sponsors and project teams on protocol development, eligibility criteria, dosing, unblinding and other trial‑related issues.
• Assess and review SAE narratives, adverse events of special interest, laboratory and ECG alerts.
• Review and comment on study documents such as protocols, informed consent forms and clinical study reports.
• Train CRAs and other team members on medical and safety aspects of oncology studies.
• Participate in internal and external project meetings and ensure timely communication of medical findings.

Required profile

• Board‑certified oncologist actively practicing or recently practicing.
• Significant experience in medical monitoring within a CRO environment.
• Strong knowledge of oncology clinical trial design and execution.
• Familiarity with national and international regulatory guidelines for clinical research.

Required skills

• Good Clinical Practice (GCP) compliance.
• Medical monitoring and safety oversight.
• Development and review of Medical Monitoring Plans and Safety Management Plans.
• Assessment of serious adverse events (SAEs) and adverse events of special interest.
• Interpretation of laboratory results and ECG alerts.