Medical Director, Oncology Clinical Development

GSK•Waltham, MA

2d•$222,750 - $371,250•Onsite

About The Position

The Medical Director, Oncology Clinical Development will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSK’s clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant scientific and medical leaders in order to lead clinical data generation activities. This individual will also have a leading role in managing effective relationships with Key External Experts. This role requires a physician capable of developing and executing oncology clinical trials in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Oncology agents.

Requirements

Medical degree with board certification/eligibility or registration qualifications in medical oncology, hematology, hematology/oncology, general surgery, internal medicine, or pathology.
Oncology experience in the pharmaceutical/biotechnology industry, clinical academic medicine, or clinical medical practice settings.
Experience in the conduct/participation of clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications

Nice To Haves

Medical degree with board / registration qualifications in medical oncology, hematology, or pathology
Board / registration certified or eligible physician with a PhD degree
Experience in Lung or Head & Neck Oncology clinical trials, including experience with study design, data review/interpretation and the overall clinical development process
Experience in regulatory requirements to support registration, including knowledge and adherence to GCP principles
Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution

Responsibilities

Collaborate with other medical directors, 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 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 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 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 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.