Qualifications
Responsibilities
Benefits
The Medical Director, Oncology Clinical Development will report to the Executive Medical Director / Clinical Development Lead (CDL), Oncology Clinical Development. This position will support our growing oncology portfolio for the treatment of hematological malignancies. The Medical Director will have the opportunity to work across early- to late-stage development and in partnership with a multi-disciplinary team of oncology drug developers.
An on-site office presence for a minimum of two days a week is required in one of GSK’s UK (London or Stevenage), US (Greater Philadelphia or Waltham), Canada (Mississauga), Switzerland (Zug) or Poland (Warsaw) campuses.
Key Responsibilities
Collaborate with physicians, scientists, regulatory professionals, biostatisticians, executive staff, and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials
Use medical expertise to contribute to the end-to-end (protocol concept to final study report) and timely delivery of clinical trials while ensuring patient safety, scientific integrity, and consistency with the clinical development strategy; demonstrate ability to incorporate global considerations into decision making
Ensure high-quality protocol development aligned with theearly 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.
Assume medical responsibility for early phase clinical trials with active participation in real-time medical monitoring, 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 and/or via oversight of delegated medical review.
Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
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.
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 authoring 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.
Serve as a core member of the Early Development Team for one or more assets in development.
Participate in Oncology Clinical Development-wide initiatives and workstreams as appropriate.
Why You?
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
Medical degree with board certification/eligibility or registration qualifications in medical oncology, hematology or hematology/oncology
Experience in the pharmaceutical/biotechnology industry, clinical academic medicine, or clinical medical practice, in the field of hematology and/or oncology
Oncology clinical drug development experience in the conduct of clinical trials (investigator-initiated, company-sponsored or cooperative group trials) and their subsequent publications
Preferred Qualifications
If you have the following characteristics, it would be a plus:
MD / PhD preferred
Clinical experience of managing patients with hematological malignancies
Oncology clinical research and drug development experience focused on hematological malignancies, including multiple myeloma
Sound understanding of biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature
Robust knowledge of preclinical/ mechanistic translational research, disease-specific research priorities, competitor landscape, and treatment guidelines evolution
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