Medical Director, Oncology Clinical Development - GI

About the role

GSK is looking for a Medical Director for its Oncology Clinical Development programme in gastrointestinal (GI) oncology. The role sits within the clinical programme team, acting as the physician responsible for medical monitoring, safety oversight and the interpretation of clinical and safety data. It works within the strategy set by the Clinical Development Lead and is a core member of the Clinical Matrix Team. Candidates who want to be based in Stevenage will be temporarily based there, with the role later moving to Cambridge, UK.

Key responsibilities

• Lead medical monitoring and safety oversight of clinical studies, including eligibility decisions, protocol queries, safety data review and participation in SRT and IDMC meetings
• Contribute to protocol development, including the informed consent form, protocol deviation management plan and study reference manual
• Interpret clinical and safety data and help shape study-level and programme-level decisions
• Help write scientific communications, including study reports, publications and congress materials, and collaborate with investigators on abstracts and manuscripts
• Contribute to regulatory documents and Health Authority interactions, and engage with Key External Experts and investigators
• Work with Clinical Operations, Biostatistics, Regulatory and Pharmacovigilance, and take part in Oncology Clinical Development-wide initiatives

Required profile

• MD (or equivalent) with board certification or eligibility in oncology, haematology or a related specialty
• Clinical experience in oncology or related areas, with exposure to clinical research or drug development
• Experience in clinical trials, including medical monitoring, safety review and data interpretation
• Knowledge of GCP, ICH guidelines and global regulatory frameworks
• Experience in cross-functional matrix teams in pharma, biotech or academic clinical trials

Preferred qualifications

• Phase I-III GI oncology clinical development experience
• Regulatory interaction experience (IND, scientific advice, NDA/MAA)
• Experience with KEEs, investigators and clinical publications
• Understanding of oncology disease biology and treatment paradigms

The role requires an on-site office presence 2-3 days a week in the UK, Switzerland or the US. Applicants submit a CV and a short cover letter.