Medical Director, Oncology Clinical Development - GU

In This Role You Will:
- Serve as the physician within the clinical program team, providing medical expertise across study design, conduct, safety oversight, and data interpretation
- Lead medical monitoring activities for clinical studies to ensure patient safety, clinical integrity, and compliance with protocol and regulatory requirements
- Interpret clinical and safety data from a physician perspective to inform study- and program-level decisions
- Partner with the Senior Scientist and cross-functional teams to integrate medical considerations into study execution
- Contribute medical expertise to protocol development and key study documents (e.g., ICF, PDMP, SRM)
- Serve as a core member of the Clinical Matrix Team (CMT)
- Engage with investigators and Key External Experts (KEEs)
- Contribute to regulatory documents and Health Authority interactions

Detailed Responsibilities:
Medical Monitoring and Safety Oversight
- Lead real-time medical decisions on patient eligibility, medical queries, and safety oversight
- Conduct/oversee medical review of clinical trial data
- Contextualize safety data with pharmacovigilance; support signal detection and benefit–risk assessment
- Ensure medical monitoring complies with GCP, ICH, and applicable regulations

Study Design and Execution
- Provide medical input into protocol development and support implementation using clinical judgement
- Provide medical input into clinical data generation aligned with objectives and the Clinical Development Plan

Data Interpretation and Scientific Contribution
- Translate findings into insights on safety, efficacy, and patient impact
- Contribute to scientific communications and clinical publications/presentations

Regulatory and External Engagement
- Provide physician expertise for regulatory submissions and Health Authority responses

Basic Qualifications (Required)
- MD (or equivalent) with board certification/eligibility in oncology, haematology, or related specialty
- Clinical experience in oncology and/or relevant therapeutic areas with exposure to clinical research/drug development
- Demonstrated clinical trial conduct experience (medical monitoring, safety review, data interpretation)
- Knowledge of GCP, ICH, and global regulatory frameworks
- Matrix team experience in pharma/biotech/academic trials
- Strong scientific communication skills

Preferred Qualifications
- Phase I–III oncology GU experience
- Prior regulatory interaction experience (e.g., IND, scientific advice, NDA/MAA)
- Experience engaging KEEs/investigators and contributing to publications/congress materials

Working model
- Hybrid: on-site at a posted location at least two days per week; remote on other days.