Overview
The Senior Medical Director, Oncology Clinical Development - GU will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Sr. 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 internal 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 an experienced professional 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.
PLEASE NOTE: This career opportunity requires an on-site office presence (minimum of two days a week) at one of GSK’s Switzerland (Zug), Poland (Warsaw), UK (Stevenage or London HQ) or US (PA or MA) sites.
KEY RESPONSIBILITIES:
- Exhibit leadership at the program and cross-functional level and 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
- Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams.
- Oversee the development of high-quality protocols 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 including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions and medical data review.
- 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.
- Contribute to the clinical and technical diligence assessment of business development opportunities, as needed.
- Understand biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature.
- Represent GSK at medical meetings, advisory boards and outreach meetings as needed/appropriate.
- Serve as a core member of the Clinical Matrix Team for one or more assets in development.
- Lead Oncology Clinical Development-wide initiatives and workstreams as appropriate.
Why you?
Basic Qualifications:
- Medical degree and completion of advanced specialty training, fellowship or country-equivalent higher-level qualification in Medical Oncology, Radiation Oncology, Urology or Internal Medicine (with GU or oncology experience).
- Experience in the global pharmaceutical/biotechnology industry in the field of GU prostate cancer.
- Experience leading GU Oncology drug development, including Phase 1, 2 and 3 clinical trial design, initiation, execution, and closure.
- Academic and/or clinical research publication history or history of medical practice in GU Oncology.
Preferred Qualifications:
- PhD in addition to medical degree and completion of advanced specialty training, fellowship or country-equivalent higher level qualification.
- Established personal and professional relationships with key external experts (KEEs) in medical oncology and credibility within the medical community.
- Experience in the clinical assessment of business development opportunities to expand a growing portfolio
- Demonstrates a thorough knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects, and/or market support.
- Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution
- Highly developed communication and interpersonal skills appropriate to the target audience and senior stakeholders, promoting effective decision-making in a highly matrixed environment
- Demonstrated track record of quality decision-making and innovative problem resolution in critical situations
- Knowledge of regulatory requirements to support registration, including knowledge and adherence to GCP principles.
Skills
Clinical Data Interpretation, Clinical Pharmacology, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Development, Drug Regulatory Affairs, Evidence Based Decision Making, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Real World Evidence (RWE), Scientific Presentations, Strategic Direction
