Early Clinical Development Medical Director, Oncology

Role Summary

GSK Oncology Early Clinical Development is seeking a highly skilled and motivated Early Clinical Development Medical Director- Oncology to join our Oncology Research and Development team. This role bridges Clinical Development and Pre-clinical/ Discovery teams to improve forward and reverse translation and increase the success of our Oncology clinical portfolio in the prostate cancer space. The Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSK’s clinical portfolio and will engage in medical dialogues with scientific leaders to lead clinical data generation activities. This position requires developing and executing oncology clinical trials to support the successful clinical development, regulatory filing, and initial market launch of oncology agents for patients with prostate cancer. An on-site presence 2 to 3 days a week is required in the UK (London or Stevenage), Switzerland (Zug), US (Upper Providence, PA) or Poland (Warsaw).

Responsibilities

• Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute early phase interventional clinical trials for patients with prostate cancer.
• Ensure high quality protocol development aligned with the overall Clinical Development Plan for assets to effectively determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
• Use medical expertise to contribute to the end to end (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into decision making.
• Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted prostate cancer patient population.
• Assume medical responsibility for clinical trials with active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions, and addressing urgent safety questions (with inclusion of Safety/ PV as relevant).
• Assume responsibility for medical review of clinical trial data, both directly as needed and/or via oversight of delegated medical review. Oversee review of data packages intended for internal and/or external IDMCs.
• Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
• Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.
• Collaborate with Principal Investigators in the evaluation and assessment of data during dose escalation and expansion studies and subsequent publications (abstracts, posters, manuscripts) associated with clinical data.
• Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of GSK’s vision.
• Understand biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature.
• 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 from accredited medical school
• Completion of a clinical residency program
• Experience in clinical research and development in Oncology
• Experience working in the pharmaceutical/biotechnology industry in prostate cancer

Preferred Qualifications

• Oncology experience in pharmaceutical/biotechnology industry preferred
• Experience in leading oncology clinical trials, including study design, data review/interpretation and the overall clinical development process
• Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution
• Experience in regulatory requirements to support registration, including knowledge and adherence to GCP principles

Additional Requirements

• On-site office-based presence 2 to 3 days a week in the UK (London or Stevenage); Switzerland (Zug); US (Upper Providence, PA) or Poland (Warsaw)