Medical Director Oncology Clinical Development

4 days ago


Collegeville, Pennsylvania, United States GlaxoSmithKline Full time
About the Role

We are seeking a highly skilled Medical Director to join our Oncology Clinical Development team at GlaxoSmithKline. As a key member of our team, you will be responsible for leading clinical research activities and advancing the development of our clinical portfolio.

Key Responsibilities
  • Collaborate with cross-functional teams to develop and execute phase 1-3 interventional clinical trials.
  • Ensure high-quality protocol development aligned with the Clinical Development Plan to effectively determine a medicine's potential efficacy, safety profile, and key areas of product differentiation.
  • Use medical expertise to contribute to the end-to-end process, ensuring scientific integrity and timely delivery of clinical trials that meet regulatory requirements.
  • Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient-reported outcomes.
  • Assume medical responsibility for clinical trials, including active participation in real-time medical monitoring of studies.
  • Review and monitor safety data in collaboration with the pharmacovigilance group.
  • Participate in the authoring of clinical study reports and regulatory documents.
  • Collaborate with Principal Investigators to evaluate and assess publications associated with clinical data.
  • Network extensively to develop long-term strategic partnerships with thought leaders.
  • Understand biological mechanisms, clinical strategy, and scientific interpretation of disease and target-based literature.
  • 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.
Requirements
  • Medical degree with board certification/eligibility or registration qualifications in medical oncology, hematology, or internal medicine.
  • Academic and/or clinical research publications or clinical medical practice in the field of oncology.
  • Clinical drug development process experience in the conduct/participation of clinical trials and their subsequent publications.
  • Regulatory experience to support registration and GCP principles.
Preferred Qualifications
  • Strong experience in the pharmaceutical industry or related oncology clinical practice experience.
  • Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends, and treatment guidelines evolution.


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