Early Clinical Development Medical Director, Oncology

GSK, Plc.•Collegeville, PA

26d•Hybrid

About The Position

GSK Oncology Early Clinical Development is seeking a highly skilled and motivated Early Clinical Development Medical Director- Oncology, to join our dynamic Oncology Research and Development team. In this role the successful candidate will create a strong link between Clinical Development and Pre-clinical/ Discovery teams to improve forward and reverse translation and, thereby, increase the success of our Oncology clinical portfolio in the prostate cancer space. This role offers a unique opportunity to bridge the gap between preclinical research and clinical development, ensuring the successful translation of innovative therapies from the lab to the clinic. The Early Clinical Development Medical Director- Oncology will report to the Executive Medical Director, Early Clinical Development Lead (ECDL)-GU, 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 for patients with prostate cancer. Please note: This position requires an on-site office -based presence 2 to 3 days a week in the UK (London or Stevenage); Switzerland (Zug); US (Upper Providence, PA. Waltham. MA or Boston. MA); or Poland (Warsaw).

Requirements

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.

Nice To Haves

Oncology experience in pharmaceutical/biotechnology industry preferred
Experience in leading oncology clinical trials, including experience with 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

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.