Medical Director-Oncology Clinical Development

Role Summary

The Medical Director, Oncology Clinical Development will lead clinical research activities to advance GSK’s oncology portfolio, engage with scientific and medical leaders to generate data, and manage relationships with external experts. The role requires developing and executing oncology clinical trials to support development, regulatory filing, and initial market launch of innovative oncology agents. The position involves collaborating across functions in a matrix environment to ensure scientific integrity and timely delivery of trials aligned with regulatory and lifecycle objectives.

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 effectively determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe
• Contribute to end-to-end study deliverables to ensure scientific integrity and timely delivery of clinical trials aligned with regulatory approvals and lifecycle management; incorporate global considerations into decision making
• Interpret and summarize study results to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient-reported outcomes and applicability to the targeted population
• Assume medical responsibility for clinical trials with real-time medical monitoring, including patient eligibility assessment, study design questions, and addressing urgent safety questions
• Oversee medical review of clinical trial data and blinded review of data for independent data monitoring committees
• 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, Pharmacology to respond to health authority and ethics queries
• Collaborate with Principal Investigators on evaluating publications (abstracts, posters, manuscripts) associated with clinical data
• Develop long-term strategic partnerships with thought leaders to support GSK’s vision
• Understand biological mechanisms, clinical strategy, and literature; be a core member of the Clinical Matrix Team
• 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 accredited medical school
• Required: Completion of a clinical residency program
• Required: Experience in clinical research and development in Oncology
• Preferred: Oncology experience in pharmaceutical/biotechnology industry
• Preferred: Experience in leading oncology clinical trials, including study design, data review/interpretation and overall development process
• Preferred: Knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends, and treatment guidelines evolution
• Preferred: Experience in regulatory requirements to support registration, including knowledge and adherence to GCP principles

Education

• Medical degree from accredited medical school
• Completion of a clinical residency program

Additional Requirements

• On-site office-based presence 2 to 3 days a week in designated locations (e.g., US: Upper Providence, PA; Waltham, MA; Boston, MA; Cambridge, MA; other US locations as applicable)