Role Summary
The Medical Director, Oncology Clinical Development will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The role is responsible for clinical research activities advancing the development of GSK’s oncology portfolio, engaging in medical dialogues with scientific and medical leaders to generate clinical data, and managing relationships with Key External Experts. The position requires a physician who can develop and execute oncology clinical trials in support of clinical development, regulatory submissions, and initial market launch of oncology agents. This position requires on-site presence 2 to 3 days a week in specified locations.
Responsibilities
- Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory and executive staff to develop and execute phase 1-3 interventional clinical trials
- Ensure high-quality protocol development aligned with the Clinical Development Plan to determine efficacy, safety, differentiation, and value for patients in a timely manner
- Contribute to end-to-end protocol concept through final study report, ensuring scientific integrity and alignment with regulatory approvals, lifecycle management, and global considerations
- Interpret and summarize study results to define safety, efficacy, pharmacokinetics/pharmacodynamics, and patient-reported outcomes for the targeted population
- Take medical responsibility for clinical trials, including real-time monitoring, patient eligibility, design questions, and urgent safety issues (with pharmacovigilance as relevant)
- Oversee medical review of clinical trial data and blinded review for independent data monitoring committees
- Review safety data in collaboration with pharmacovigilance for active studies
- Contribute to clinical study reports and regulatory documents; collaborate with Regulatory Affairs, CMC, Toxicology, Research, and Pharmacology to respond to health authority queries
- Collaborate with Principal Investigators on publications (abstracts, posters, manuscripts) related to clinical data
- Network to develop strategic partnerships with thought leaders internally and externally
- Understand biological mechanisms, clinical strategy, disease interpretation, and literature
- Serve as a core member of the Clinical Matrix Team for one or more assets in development
- Represent Clinical Development on disease area strategy, integrated evidence, and medical affairs strategy teams
- Participate in Oncology Clinical Development-wide initiatives and workstreams as appropriate
Qualifications
- Required: Medical degree from an accredited medical school
- Required: Completion of a clinical residency program
- Required: Experience in clinical research and development in Oncology
Preferred Qualifications
- Oncology experience in pharmaceutical/biotechnology industry
- Experience in leading oncology clinical trials, including study design, data review/interpretation, and overall development process
- Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends, and treatment guidelines evolution
- Experience in regulatory requirements to support registration, including knowledge and adherence to GCP principles
Education
- Medical degree from an accredited medical school
- Clinical residency program completion
Additional Requirements
- On-site presence 2-3 days per week in specified locations