Early Clinical Development Medical Director, Oncology

2 tygodni temu


Warszawa, Polska GSK Pełny etat

Early Clinical Development Medical Director, Oncology We are seeking an experienced Early Clinical Development Medical Director, Oncology to join our dynamic Oncology Research and Development team. The successful candidate will bridge preclinical research and clinical development, ensuring the successful translation of innovative therapies from the lab to the clinic. This position requires an on-site office‑based presence 2–3 days a week in the UK (London or Stevenage), Switzerland (Zug), the US (Upper Providence, PA; Waltham, MA; or Boston, MA), or Poland (Warsaw). Key Responsibilities Collaborate with physicians, scientists, regulatory professionals, biostatisticians, and executive staff 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 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 concept to final study report) process, ensuring scientific integrity and timely delivery of clinical trials consistent with the clinical development strategy for regulatory approvals and lifecycle management. Interpret and summarize study results to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient‑reported outcomes, and assess applicability of data to the targeted prostate cancer patient population. Assume medical responsibility for clinical trials, actively participating in real‑time medical monitoring, patient eligibility assessment, study design questions, and addressing urgent safety questions. Oversee medical review of clinical trial data, both directly and via oversight of delegated medical review, and review safety data in collaboration with the pharmacovigilance group for active studies. Participate in authoring clinical study reports and regulatory documents, responding to health authority and ethics committee queries. Collaborate with Principal Investigators to evaluate data during dose escalation and expansion studies, and support subsequent publications (abstracts, posters, manuscripts). Network extensively to develop long‑term strategic partnerships with thought leaders both internally and externally, supporting GSK’s vision. 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 prostate cancer. Preferred Qualifications Oncology experience in the 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 guideline evolution. Experience in regulatory requirements to support registration, including knowledge and adherence to GCP principles. Equal Opportunity Employer GSK is an Equal Opportunity Employer. This ensures that all qualified applicants 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. #J-18808-Ljbffr



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