Senior Medical Director, Oncology Clinical Development - GU
6 days ago
London
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 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. • Exhibit leadership at the program and cross‑functional level and collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory personnel, 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 determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patients 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 are consistent 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, patient eligibility assessment, study design questions and medical data review., • Review/monitor safety data in collaboration with the 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, and Pharmacology to respond to health‑authority and ethics‑committee queries., • Collaborate with Principal Investigators to evaluate and assess 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., • 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., • PhD in addition to a 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 it 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‑guideline 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 adherence to GCP principles. Clinical Data Interpretation, Clinical Pharmacology, Clinical Trial Design, 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. For U.S. locations (e.g., Cambridge, MA; Waltham, MA; Rockville, MD; San Francisco, CA) the annual base salary range for new hires is $284,250 to $473,750, adjusted for location, skills, experience and market rate. The position offers an annual bonus and eligibility to participate in a share‑based long‑term incentive program. Benefits include health care and other insurance (for employee and family), retirement benefits, paid holidays, vacation, paid caregiver/parental and medical leave. Similar compensation ranges apply in other countries, with local adjustments for market, skill level and location. GSK is a global biopharma company dedicated to uniting science, technology and talent to get ahead of disease. We aim to positively impact the health of 2.5 billion people by the end of this decade. Our focus areas encompass respiratory, immunology and inflammation, oncology, HIV, and infectious diseases, and we are committed to fostering an environment where people can thrive and focus on what matters most. GSK is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Should you require any adjustments to our process to demonstrate your strengths and capabilities, contact us at HR.AmericasSC‑CS@gsk.com. 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