Medical Director, Oncology Clinical Development

Role Summary

The Medical Director, Oncology Clinical Development (Breast and Gynecologic Cancers) will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. They will be responsible for clinical research activities advancing GSK’s clinical portfolio, lead medical dialogues with scientific and medical leaders to drive clinical data generation, and manage relationships with Key External Experts. This role supports the oncology antibody drug conjugate portfolio for solid tumors and collaborators across early to late-stage development with a multi-disciplinary team.

Responsibilities

• Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory and executive staff in a 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 efficacy, safety, product differentiation and value to patients in a timely manner
• Contribute to end-to-end trial processes to ensure scientific integrity and timely delivery aligned with regulatory approvals and lifecycle management; incorporate global considerations into decision making
• Interpret and summarize study results for safety, efficacy, pharmacokinetic/pharmacodynamic, and patient-reported outcomes and applicability to the targeted population
• Assume medical responsibility for clinical trials including real-time medical monitoring, patient eligibility assessment, design questions, and urgent safety questions (with Safety/PV as relevant)
• Oversee medical review of trial data and blinded data packages for independent data monitoring committees as needed
• Review/monitor safety data in collaboration with pharmacovigilance for active studies
• Contribute to 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 on evaluating publications (abstracts, posters, manuscripts) of clinical data
• Develop long-term strategic partnerships with thought leaders internally and externally
• Understand biological mechanisms, clinical strategy, and scientific interpretation of disease and targets
• Serve as a core member of the Clinical Matrix Team for one or more assets; represent Clinical Development on disease area strategy 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: Clinical experience in medical oncology, hematology, or gynecologic oncology
• Required: Experience in clinical research and development

• Preferred: Oncology clinical research and drug development experience focused on gynecologic cancer or breast cancer
• Preferred: Experience in the pharmaceutical/biotechnology industry; clinical academic medicine or clinical medical practice in oncology or gynecologic oncology
• Preferred: Oncology clinical drug development experience in conducting/participating in trials (investigator-initiated, company-sponsored, or cooperative group) and subsequent publications
• Preferred: Regulatory experience to support registration and good clinical practice principles
• Preferred: Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends, and treatment guideline evolution

Additional Requirements

• On-site office presence for a minimum of two days a week at one of GSK’s campuses (London, Stevenage, PA, MA, Zug, or Warsaw)