Medical Director-Oncology Clinical Development

Overview

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success.

We’re uniting science, technology, and talent to get ahead of disease together.

Position requires an on‑site office‑based presence 2 to 3 days a week in the following locations: UK (London or Stevenage), Switzerland (Zug), US (Upper Providence, PA; Waltham, MA; Boston, MA), or Poland (Warsaw).

• 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 patients in the shortest possible timeframe.
• Use medical expertise to contribute to the end‑to‑end process (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials consistent 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 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 blinded review of data packages intended for IDMCs.
• Review/monitor safety data in collaboration with the 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, and Pharmacology to respond to health authority and ethics committee queries.
• Collaborate with Principal Investigators in the evaluation and assessment of 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 work streams as appropriate.

• Medical degree from an accredited medical school.
• Completion of a clinical residency program.
• Experience in clinical research and development in oncology.

• 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 guideline evolution.
• Experience in regulatory requirements to support registration, including…