Director, Clinical Science – Oncology Clinical Development GYN

In This Role You Will:

• Provide scientific leadership across defined components of study-level activities, including protocol development, study design, data review, and interpretation, within the strategic direction set by the CDL
• Serve as a core member of the Clinical Matrix Team (CMT), ensuring scientific alignment across study objectives, timelines, and deliverables
• Provide scientific insight to the CDL and Senior Scientist to inform asset-level strategy, benefit–risk assessment, and programme-level decision-making
• Ensure the scientific quality and consistency of key clinical and regulatory documents, including protocols, Investigator’s Brochures, Clinical Study Reports, and submission materials
• Apply scientific and clinical expertise to analyse and interpret data, ensuring rigour, integrity, and relevance to the target patient population
• Engage with internal and external stakeholders, including investigators and Key External Experts, to support study execution and scientific exchange
• Contribute to a culture of scientific excellence, innovation, and continuous improvement within Oncology Clinical Development

Detailed Responsibilities:

Study Design and Execution

• Provide scientific input into protocol development and study design, ensuring robustness, feasibility, and alignment with CDP-defined objectives and regulatory requirements
• Author or co-author key study documents (e.g., Clinical Study Proposals), contributing to preparation and presentation at governance forums such as Protocol Review Boards
• Support study conduct by addressing scientific questions, ensuring data integrity, and maintaining alignment with protocol and regulatory standards
• Provide scientific input into study-level decisions related to protocol implementation and study conduct, within the strategic framework defined by the CDL
• Present and support the scientific rationale and study design at Investigator Meetings and respond to scientific inquiries from study sites
• Support implementation of study-level Go/No-Go criteria aligned to the asset-level decision framework defined by the CDL

Data Generation, Analysis, and Interpretation

• Analyse and interpret clinical data to generate insights on safety, efficacy, and patient populations
• Integrate data from internal and external sources (e.g., literature, competitor data, emerging science) to inform study and programme understanding
• Provide scientific input into data review and interpretation activities, in collaboration with Medical Directors and pharmacovigilance
• Translate study findings into clear scientific insights to inform programme progression and support CDL-led decision-making

Clinical and Regulatory Deliverables

• Contribute to development of clinical and regulatory documents, including protocols, Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and submission materials
• Ensure scientific accuracy, consistency, and quality across study documentation
• Support preparation of regulatory submissions and responses to Health Authority queries
• Contribute to regulatory reporting requirements (e.g., DSURs, INDSRs) and ensure alignment with regulatory standards

Cross-Functional Collaboration & Scientific Contribution

• Serve as a core member of the CMT, partnering with Clinical Operations, Statistics, Safety, Regulatory, and Medical Affairs to support integrated study delivery
• Provide scientific expertise to cross-functional discussions, including integrated evidence planning and disease-area forums, as appropriate
• Participate in internal and external scientific interactions with investigators, Key External Experts, advisory boards, and collaborators
• Contribute to scientific communications, including publications, congress presentations, and study-related materials

Ways of Working & Continuous Improvement

• Identify scientific and operational risks at the study level and provide input into mitigation strategies
• Support and drive implementation of consistent ways of working and process improvements across the programme
• Participate in Oncology Clinical Development initiatives and workstreams to strengthen standards, processes, and capabilities
• Engage in ongoing development to deepen scientific expertise, expand disease-area knowledge, and build broader clinical development capabilities