Medical Director, Oncology Clinical Development

Role Summary

Medical Director, Oncology Clinical Development. Reports to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. Responsible for clinical research activities to advance the development of the clinical portfolio and for engaging in medical dialogues with scientific and medical leaders to lead clinical data generation activities. Leads relationships with Key External Experts. Requires a physician capable of developing and executing oncology clinical trials to support successful clinical development, regulatory filing and initial market launch of innovative 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 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 protocol concept to final study report to ensure scientific integrity and timely delivery of clinical trials aligned with regulatory approvals, reimbursable medicines, and lifecycle management; incorporate global considerations into decision making
• Interpret and summarize study results to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient-reported outcomes relevant to the target population
• Assume medical responsibility for clinical trials with active participation in real-time medical monitoring, including patient eligibility assessment, study design questions, and addressing urgent safety questions
• Medical review of clinical trial data and oversight of blinded data review for IDMCs
• Review/monitor safety data in collaboration with pharmacovigilance for active clinical 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 committee queries
• Collaborate with Principal Investigators in evaluating publications (abstracts, posters, manuscripts) associated with clinical data
• Network to develop long-term strategic partnerships with thought leaders internally and externally to support GSK’s vision
• Understand biological mechanisms, clinical strategy, and literature interpretation relevant to disease and targets
• 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

• 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 experience in the fields noted above
• Documented academic and/or clinical research publication history or history of medical practice in the fields noted above
• Strong working knowledge of the clinical drug development process with experience in the conduct/participation of clinical trials and their publications
• Experience in regulatory requirements to support registration, including knowledge and adherence to GCP principles

Education

Skills

• Medical expertise across end-to-end clinical development, trial design and data interpretation
• Strategic collaboration and networking with external thought leaders
• Strong communication and regulatory documentation skills

Additional Requirements

• On-site presence 2 to 3 days a week in specified locations (UK, Switzerland, US, or Poland)