Medical Director

3 days ago


Collegeville, Indiana, United States GlaxoSmithKline Full time

Job Summary

The Medical Director - Oncology Clinical Development will lead clinical research activities to advance the development of GSK's oncology portfolio. This role will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development.

Key Responsibilities

  • Collaborate with physicians, scientists, regulatory professionals, biostatisticians, and other stakeholders to develop and execute phase 1-3 interventional clinical trials.
  • Ensure high-quality protocol development aligned with the Clinical Development Plan to 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.
  • Assume medical responsibility for clinical trials, including real-time medical monitoring, patient eligibility assessment, and addressing urgent safety questions.
  • Review and monitor safety data in collaboration with the pharmacovigilance group.
  • Participate in the authoring of clinical study reports and regulatory documents.

Requirements

  • Medical degree with board certification/eligibility or registration qualifications in medical oncology, hematology, hematology/oncology, general surgery, or internal medicine.
  • Experience in the pharmaceutical/biotechnology industry, clinical academic medicine, or clinical medical practice settings in oncology.
  • 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.

About GSK

GSK is a global biopharma company committed to uniting science, technology, and talent to get ahead of disease together. We focus on the science of the immune system and invest in four core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology.



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