Medical Director, Oncology Clinical Development

About the role

The Medical Director, Oncology Clinical Development will report to the Executive Medical Director / Clinical Development Lead (CDL), Oncology Clinical Development. This position supports our growing oncology portfolio for the treatment of hematological malignancies.

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
• 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 the early 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

Qualifications

• 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

• 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

Benefits

Annual base salary range for new hires in this position ranges $222,750 to $371,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.