Medical Director, Oncology Clinical Development

Role Summary

Medical Director, Oncology Clinical Development who will lead clinical research activities for advancing the development of GSK’s oncology portfolio, engaging with scientific leaders to drive clinical data generation, and managing relationships with external experts. The role requires a physician capable of developing and executing oncology clinical trials to support regulatory filings and initial market launch of transformative oncology agents.

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 efficacy, safety, product differentiation, and value to patient in the shortest timeframe
• Contribute to end-to-end clinical 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 to define safety, efficacy, pharmacokinetic/pharmacodynamic data and patient-reported outcomes for targeted populations
• Assume medical responsibility for clinical trials with real-time medical monitoring, including patient eligibility, 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 data reviews for IDMCs
• 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 to evaluate and assess publications (abstracts, posters, manuscripts) associated with clinical data
• Network to develop long-term strategic partnerships with thought leaders internally and externally
• Understand biological mechanisms, clinical strategy, and literature interpretation; contribute to disease area strategy and medical affairs strategy teams
• Serve as a core member of the Clinical Matrix Team for assets in development
• 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 publication history or equivalent
• Strong working knowledge of the clinical drug development process with experience in conduct/participation of clinical trials and publications
• Experience in regulatory requirements to support registration, including knowledge and adherence to GCP principles

Preferred Qualifications

• Board/registration certified or eligible physician with a PhD degree
• 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, clinical practice trends and evolving guidelines