Description
The Medical Director, Oncology Clinical Development - GI is the physician within the clinical programme team, bringing medical expertise, clinical judgement, and a patient-centred perspective to the design, conduct, and interpretation of clinical studies.
In this role, you will:
- Serve as the physician within the clinical programme team, providing medical expertise across study design, conduct, safety oversight, and data interpretation
- Lead medical monitoring activities for clinical studies, ensuring patient safety, clinical integrity, and compliance with the protocol and regulatory requirements
- Interpret clinical and safety data from a physician perspective, generating insights that inform study-level and programme-level decisions
- Partner with the Senior Scientist and cross-functional teams to ensure medical considerations are integrated into study execution and delivery
- Contribute medical expertise to protocol development, ensuring clinical relevance, patient safety, and feasibility
- Serve as a core member of the Clinical Matrix Team (CMT), providing the medical voice in study-level discussions and cross-functional decision-making
- Engage with investigators and Key External Experts (KEEs) to support study conduct, scientific exchange, and external representation of the programme
- Contribute to regulatory documents, Health Authority interactions, and scientific communications from a physician perspective
Detailed Responsibilities:
- Medical Monitoring and Safety Oversight: Lead medical monitoring activities for assigned clinical studies, including real-time clinical decision-making on patient eligibility, protocol-related medical queries, and safety oversight
- Study Design and Execution: Provide medical input into protocol development, ensuring clinical relevance, patient safety, and operational feasibility
- Data Interpretation and Scientific Contribution: Interpret clinical data from a physician perspective, translating findings into insights on safety, efficacy, and patient impact
- Regulatory and External Engagement: Contribute medical expertise to regulatory documents and Health Authority interactions
- Cross-Functional Collaboration and Clinical Matrix Team: Serve as a core member of the Clinical Matrix Team (CMT), providing medical leadership within study execution
Basic Qualifications:
- MD (or equivalent medical degree) with board certification or eligibility in oncology, haematology, or a related specialty
- Clinical experience in oncology and/or relevant therapeutic areas, with direct exposure to clinical research or drug development
- Demonstrated experience in clinical trial conduct, including medical monitoring, safety review, and clinical data interpretation
- Strong working knowledge of clinical development processes, including GCP, ICH guidelines, and global regulatory frameworks
Preferred Qualifications:
- Experience in pharmaceutical or biotechnology clinical development across Phase I–III GI oncology studies
- Prior experience contributing to regulatory interactions (e.g., IND submissions, scientific advice, NDA/MAA filings)
- Demonstrated experience engaging with Key External Experts (KEEs), investigators, and scientific collaborators in oncology