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Medical Director, Oncology Clinical Development

GSK
Full-time
Remote friendly (Boston, MA)
United States
Clinical Research and Development

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Role Summary

Medical Director, Oncology Clinical Development. Responsible for clinical research activities advancing GSKโ€šร„รดs oncology portfolio, engaging in medical dialogues with scientific and medical leaders, and managing relationships with key external experts. Requires a physician to develop and execute oncology clinical trials supporting clinical development, regulatory filing, and initial market launch of innovative oncology agents. On-site presence 2โ€šร„รฌ3 days a week in specified locations.

Responsibilities

  • 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
  • Ensure high quality protocol development aligned with the Clinical Development Plan to determine efficacy, safety, value to patient, and differentiation in the shortest timeframe
  • Contribute to end-to-end clinical trial development to ensure scientific integrity and timely delivery aligned with regulatory approvals and lifecycle management, incorporating global considerations
  • Interpret and summarize study results to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient-reported outcomes for the targeted population
  • Assume medical responsibility for clinical trials with real-time medical monitoring, including eligibility assessment, design questions, and urgent safety questions
  • Review clinical trial data and oversee blinded review of data packages for IDMCs
  • Review/monitor safety data in collaboration with pharmacovigilance for active studies
  • Participate in authoring clinical study reports and regulatory documents; collaborate with Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics queries
  • Collaborate with Principal Investigators on evaluation of publications associated with clinical data
  • Develop long-term strategic partnerships with thought leaders to support GSKโ€šร„รดs vision
  • Understand biological mechanisms, clinical strategy, and interpretation of disease and literature
  • Serve as a core member of the Clinical Matrix Team for assets in development
  • Represent Clinical Development on disease area strategy, integrated evidence, and medical affairs strategy teams
  • Participate in Oncology Clinical Development-wide initiatives and workstreams as appropriate

Qualifications

  • Medical degree with completion of post-medical education residency
  • Board/registration in medical oncology, hematology, pathology, or internal medicine
  • Oncology experience in pharmaceutical/biotechnology industry and clinical practice in indicated fields
  • Documented academic and/or clinical research publication history or clinical practice history in relevant fields
  • Strong knowledge of the clinical drug development process and experience in conducting/participating in clinical trials and publications
  • Experience in regulatory requirements to support registration and knowledge of GCP

Preferred Qualifications

  • Board/registration certified or eligible with a PhD
  • Experience leading oncology clinical trials, including study design, data review/interpretation, and overall development process
  • Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, and treatment guidelines evolution

Skills

  • Strategic collaboration and relationship management with external experts
  • Medical monitoring of trials and risk assessment
  • Regulatory documentation and cross-functional coordination
  • Scientific literature interpretation and data-driven decision making

Education

  • Medical degree; residency completed; board/registration in relevant specialty

Additional Requirements

  • On-site presence 2โ€šร„รฌ3 days per week in specified locations (UK, Switzerland, US, or Poland)