Senior Medical Director / Medical Monitor

About the role

The Senior Medical Director (Medical Monitor) provides medical oversight for clinical trials, ensuring that company SOPs, client directives, Good Clinical Practice and regulatory requirements are fully adhered to. The role involves direct interaction with investigators, sponsors and internal teams to guide safety monitoring and support business development activities.

Key responsibilities

• Provide overall medical oversight of clinical trials, ensuring compliance with SOPs, ICH guidelines, GCP and regulatory standards.
• Monitor safety variables, adverse events, laboratory abnormalities and patient status; review and interpret serious adverse events and special‑interest events.
• Conduct signal detection activities, generate aggregate safety reports and contribute to label updates and risk‑management plans.
• Prepare and review medical content for CSR, IND/NDA reports, ICSR, periodic safety reports, RMP, REMS and CTD modules.
• Deliver therapeutic and protocol training to study teams and investigators as required.
• Maintain clear communication with associates, clients and investigators to ensure proper execution of study procedures.

Required profile

• MD or equivalent degree; active medical licensure preferred.
• Clinical experience in hematology/oncology (≈2 years) combined with industry experience in clinical trials (1‑2 years) or pharmacovigilance (≈2 years).
• Strong knowledge of ICH guidelines, GCP and regulatory requirements for clinical research.
• Proven ability to provide medical consultation, interpret safety data and communicate findings to multidisciplinary teams.