Medical Director, Oncology Clinical Development

Role Summary

Medical Director, Oncology Clinical Development responsible for clinical research activities to advance GSK’s oncology portfolio, engaging medical leaders to drive clinical data generation, and managing relationships with Key External Experts. Requires a physician capable of developing and executing oncology clinical trials to support development, regulatory filing, and initial market launch of innovative oncology agents. This is an on-site role 2–3 days a week in designated locations.

Responsibilities

• Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials
• Ensure high quality protocol development aligned with the Clinical Development Plan to determine a medicine‚Äôs potential efficacy, safety profile, key differentiators and value to patient in the shortest possible timeframe
• Contribute to end-to-end trial delivery (protocol concept to final study report) ensuring scientific integrity and timely delivery aligned with regulatory approvals, lifecycle management, and global decision making
• Interpret and summarize study results to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient-reported outcomes for the targeted population
• Assume medical responsibility for clinical trials with real-time medical monitoring, patient eligibility assessment, study design questions, and urgent safety issues (with Safety/PV as relevant)
• Medical review of clinical trial data and oversight of delegated medical review; oversee blinded review of data for IDMCs
• Review/monitor safety data in collaboration with pharmacovigilance for active studies
• Participate in authoring of clinical study reports and regulatory documents; collaborate with Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to inquiries
• Collaborate with Principal Investigators on publications (abstracts, posters, manuscripts) from clinical data
• Network to develop long-term strategic partnerships with thought leaders internally and externally
• Understand biological mechanisms, clinical strategy, and interpretation of disease and literature
• 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 and workstreams as appropriate

Qualifications

• Medical degree with completion of post medical education clinical residency training
• Board/registration qualifications in medical oncology, hematology, pathology or internal medicine
• Oncology experience in pharmaceutical/biotechnology industry and clinical practice in the above fields
• Documented academic and/or clinical research publications or history of medical practice in the fields noted
• Strong working knowledge of the clinical drug development process with experience in conducting/participating in clinical trials and publications
• Experience in regulatory requirements to support registration, including knowledge and adherence to GCP

Preferred Qualifications

• Board/registration certified or eligible physician with a PhD
• Experience leading oncology clinical trials, including study design, data review/interpretation, and overall development process
• Knowledge of disease-specific research priorities, public health needs, competitor landscape, practice trends, and treatment guidelines evolution