Medical Director, Oncology Clinical Development

Role Summary

Medical Director, Oncology Clinical Development reporting to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. Responsible for clinical research activities to advance GSK’s clinical portfolio, engaging in medical dialogues with scientific and medical leaders to lead data generation, and managing relationships with Key External Experts. Requires a physician capable of developing and executing oncology clinical trials to support regulatory filing and initial market launch of Oncology agents.

Responsibilities

• Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory and executive staff in a complex matrix 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, product differentiation and value to patients in a timely timeframe
• Contribute to end-to-end protocol concept to final study report to ensure scientific integrity and timely delivery aligned with regulatory approvals, lifecycle management, and global considerations
• Interpret and summarize study results to define safety, efficacy, PK/PD, and patient-reported outcomes for the targeted population
• Assume medical responsibility for trials with real-time medical monitoring, including patient eligibility, design questions, and urgent safety issues (including Safety/ PV as relevant)
• Review medical data, oversee delegated medical reviews, and supervise blinded data package reviews for IDMCs
• Review safety data in collaboration with pharmacovigilance for active studies
• Co-author clinical study reports and regulatory documents, and collaborate with Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority/ethics queries
• Collaborate with Principal Investigators on evaluation of publications (abstracts, posters, manuscripts) in relation to clinical data
• Develop long-term strategic partnerships with thought leaders internally and externally to support GSK‚Äôs vision
• Understand biological mechanisms, clinical strategy, and disease literature interpretation
• 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 with completion of post-medical education residency
• Board/registration in medical oncology, hematology, pathology or internal medicine
• Oncology experience in pharmaceutical/biotech industry and clinical practice in the fields noted
• Academic/clinical research publication history or relevant medical practice history
• Strong knowledge of the clinical drug development process and experience in conducting/participating in clinical trials and publications
• Experience with regulatory requirements to support registration 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

Education

• Medical degree; residency training completed
• Board/registration in oncology, hematology, pathology, or internal medicine (preferred)