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Medical Director- Oncology Clinical Development

Job in Reston, Fairfax County, Virginia, 22090, USA
Listing for: GSK
Full Time position
Listed on 2025-12-25
Job specializations:
  • Healthcare
Job Description & How to Apply Below

Position Summary:

GSK Oncology Clinical Development is seeking a highly skilled and motivated 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 other functions in the clinical matrix team to increase the success of our Oncology clinical portfolio in the GU cancer space.

Key Responsibilities:
  • Collaborate with physicians, scientists, regulatory professionals and biostatisticians 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 determine a medicine’s potential efficacy, safety profile and value to patients in the shortest possible timeframe.
  • Use medical expertise to contribute to the end‑to‑end protocol development and study execution to ensure scientific integrity and timely delivery of clinical trials.
  • Interpret and summarize study results 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, including real‑time medical monitoring, patient eligibility assessment, study design questions and urgent safety questions.
  • Oversee review of data packages intended for internal and external independent data monitoring committees.
  • Review safety data in collaboration with pharmacovigilance group for active clinical studies.
  • Collaborate with regulatory affairs and related cross‑functional teams to respond to health authority and ethics committee queries.
  • Collaborate with principal investigators on evaluation and assessment of data during dose escalation and expansion studies and subsequent publications (abstracts, posters, manuscripts).
  • Network extensively to develop long‑term strategic partnerships with thought leaders both internally and externally.
  • 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.
Basic Qualifications:
  • Medical degree from an 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 GU prostate cancer.
Preferred Qualifications:
  • Oncology experience in pharmaceutical/biotechnology industry.
  • Experience leading oncology clinical trials, including 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.
Equal Opportunity Employer Statement:

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, military service or any basis prohibited under federal, state or local law.

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