Job Description
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. The 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.
On-site office presence is required (minimum of two days a week) at one of GSK's locations in Zug (Switzerland), Warsaw (Poland), Stevenage or London (UK), or Pennsylvania or Massachusetts (USA).
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 patients in the shortest possible timeframe
- Use medical expertise to contribute to end‑to‑end clinical development (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials, 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, 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 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 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 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
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 or fellowship or 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 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 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
- 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
Salary ranges (annually) are location‑specific:
- United States (CA, MD, WI): $284,250 to $473,750, plus annual bonus and share‑based long‑term incentive program eligibility
- Poland: PLN 593,250 to PLN 988,750 gross, with potential bonus based on defined criteria
Benefits include health care and other insurance benefits for employee and family, retirement benefits, paid holidays, vacation, paid caregiver/parental and medical leave
GSK is an Equal Opportunity Employer. This ensures that 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.
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