Early Clinical Development Medical Director, Oncology

Role Summary

GSK Oncology Early Clinical Development is seeking a highly skilled Medical Director- Oncology to join the Oncology Research and Development team. The role will create a strong link between Clinical Development and Pre-clinical/Discovery teams to improve translation and increase the success of the Oncology clinical portfolio in the prostate cancer space, bridging preclinical research and clinical development to translate therapies from lab to clinic. The Medical Director will report to the Executive Medical Director, Early Clinical Development Lead (ECDL)-GU, Oncology Clinical Development, and will be responsible for clinical research activities advancing the development of GSK’s clinical portfolio and engaging in medical dialogues with scientific leaders to lead clinical data generation activities.

This role requires a physician capable of developing and executing oncology clinical trials to support clinical development, regulatory filing, and initial market launch of innovative Oncology agents for patients with prostate cancer. An on-site office-based presence is required 2 to 3 days a week in the UK, Switzerland, US or Poland.

Responsibilities

• Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute early phase interventional clinical trials for patients with prostate cancer.
• Ensure high quality protocol development aligned with the overall Clinical Development Plan for assets to determine potential efficacy, safety profile, product differentiation, and value to patients in the shortest timeframe.
• Contribute to end-to-end protocol development to ensure scientific integrity and timely delivery of trials aligned with regulatory approvals, lifecycle management, and global decision making.
• Interpret and summarize study results to define safety, efficacy, PK/PD, and patient-reported outcomes and applicability to the targeted patient population.
• Take medical responsibility for clinical trials with real-time medical monitoring, including patient eligibility, study design questions, and urgent safety issues.
• Oversee medical review of clinical trial data and data packages for internal and external IDMCs as needed.
• Review/monitor safety data in collaboration with pharmacovigilance for active studies.
• Participate in authoring 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 in data evaluation during dose escalation and expansion studies and subsequent publications.
• Network to develop long-term strategic partnerships with thought leaders internally and externally.
• Understand biological mechanisms, clinical strategy, and literature interpretation; serve as a core member of the Clinical Matrix Team for one or more assets.
• Represent Clinical Development on disease area strategy, integrated evidence, and medical affairs strategy teams; participate in Oncology Clinical Development-wide initiatives.

Qualifications

• Required: Medical degree from accredited medical school
• Required: Completion of a clinical residency program
• Required: Experience in clinical research and development in Oncology
• Required: Experience working in the pharmaceutical/biotechnology industry in prostate cancer
• Preferred: Oncology experience in pharmaceutical/biotechnology industry
• Preferred: Experience leading oncology clinical trials, including study design, data review/interpretation, and overall development process
• Preferred: Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends, and treatment guidelines evolution
• Preferred: Experience with regulatory requirements to support registration, including knowledge and adherence to GCP principles

Education

• Medical degree from accredited medical school (included in Required)

Additional Requirements

• On-site office-based presence 2 to 3 days a week in the UK (London or Stevenage), Switzerland (Zug), US (Upper Providence, PA) or Poland (Warsaw)