Medical Director / Senior Medical Director – Hematology/Oncology

About the role

The Medical Director / Senior Medical Director will provide medical oversight for hematology/oncology clinical trials, ensuring compliance with company SOPs, client directives, Good Clinical Practice and regulatory requirements. The role involves direct interaction with investigators, sponsors and internal teams to support trial execution and business development.

Key responsibilities

• Oversee safety monitoring, adverse event review, and data validation for assigned studies.
• Present at investigator and sponsor meetings, providing medical consultation and therapeutic training.
• Review and author regulatory deliverables such as CSR, IND/NDA reports, ICSR, PBRER, PSUR, DSUR, REMS, RMP and CTD modules.
• Manage pharmacovigilance activities, signal detection, label updates and risk‑management documentation for marketed products.
• Ensure adherence to ICH guidelines, client SOPs and corporate policies across all project phases.

Required profile

• MD with specialization in Oncology or Hemato‑Oncology and an active medical license.
• Extensive experience in clinical trial oversight and pharmacovigilance.
• Strong knowledge of regulatory requirements and ICH guidelines.
• Proven ability to communicate medical information clearly to internal and external stakeholders.

Required skills

• Pharmacovigilance
• Clinical trial oversight
• ICH guideline compliance
• Medical data review and analysis