Medical Director, Oncology Clinical Development - GU

The Medical Director, Oncology Clinical Development - GU (Genitourinary) is the physician within the clinical program 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 program 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 program-level decisions led by the CDL
• 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 within the framework defined by the CDL
• 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 program
• 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
• Conduct and oversee medical review of clinical trial data, both directly and through oversight of delegated medical review activities
• Interpret and contextualize safety data in collaboration with pharmacovigilance, ensuring appropriate signal detection, escalation, and benefit–risk assessment at the study level
• Participate in safety review forums, including Safety Review Team (SRT) discussions, Independent Data Monitoring Committee (IDMC) data reviews, and internal governance as required
• Ensure medical monitoring activities are conducted in compliance with GCP, ICH guidelines, and applicable regulatory frameworks

Study Design and Execution

• Provide medical input into protocol development, ensuring clinical relevance, patient safety, and operational feasibility within the clinical strategy defined by the CDL
• Apply clinical judgement to support protocol implementation, addressing medical questions that arise during study conduct and ensuring consistency with the study’s scientific objectives
• Partner with the Senior Scientist to ensure that medical considerations are fully integrated into study execution, data generation, and operational delivery
• Contribute to the development and review of key study documents, including the Informed Consent Form (ICF), protocol deviation management plan (PDMP), and study reference manual (SRM)
• Provide medical input into clinical data generation activities, ensuring alignment with study objectives, patient safety considerations, and the Clinical Development Plan (CDP)

Data Interpretation and Scientific Contribution

• Interpret clinical data from a physician perspective, translating findings into insights on safety, efficacy, and patient impact that inform decision-making by the CDL
• Contribute to study-level and program-level data interpretation, supporting the CDL’s assessment of benefit–risk and clinical positioning
• Contribute to the development of scientific communications, including study reports, clinical study summaries, publications, and congress materials
• Collaborate with investigators on the evaluation and development of abstracts, posters, and manuscripts derived from clinical program data
• Maintain current knowledge of the asset’s biological mechanism, disease landscape, evolving treatment paradigms, and competitive environment to inform clinical interpretation

Regulatory and External Engagement

• Contribute medical expertise to regulatory documents and Health Authority interactions, including responses to clinical and safety queries
• Support preparation of materials for regulatory submissions, advisory boards, and external engagements, providing the physician perspective on clinical data and safety
• Engage with Key External Experts (KEEs), investigators, and scientific collaborators to support study conduct, scientific exchange, and relationship development
• Represent the medical perspective at cross-departmental interactions, including Integrated Evidence Team (IET) and Medical Affairs strategy discussions, as delegated by the CDL
• Contribute to the clinical and technical diligence assessment of business development opportunities as requested

Cross-Functional Collaboration and Clinical Matrix Team

• Serve as a core member of the Clinical Matrix Team (CMT), providing medical leadership within study execution
• Contribute medical expertise to disease area strategy, integrated evidence planning, and Medical Affairs discussions as appropriate
• Collaborate across functions , including Clinical Operations, Biostatistics, Regulatory, and Pharmacovigilance , to ensure alignment on study objectives, patient safety, and data quality
• Contribute to Oncology Clinical Development-wide initiatives and workstreams

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
• Ability to apply clinical judgement to support study design, patient safety, and real-time medical decision-making within a structured clinical development framework
• Experience operating effectively within cross-functional matrix teams in a pharmaceutical, biotechnology, or academic clinical trial environment
• Strong scientific communication skills, with the ability to translate clinical data into clear insights for internal and external audiences