SCHOOL OF MEDICINE

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

REQUIREMENTS:

• M.D., or Ph.D. with knowledge of translational drug development.
• A track record of completing research projects and recent first/ lead authorship in high impact scientific journals

• Development of a clinical trial protocol of combination therapy.
• Preparation of regulatory documents for submission to the Food and Drug Administration
• Oversight of a multidisciplinary team that is currently preparing for clinical trials. Co-ordination and management of various teams across the Office of Regulatory Affairs and Quality (ORAQ), the Marcus Center for Cellular Cures (MC3) cGMP and quality team, the Preston Robert Tisch Brain Tumor Center (PRTBTC), the Duke Investigational Chemotherapy Service (ICS), Home Health infusion team and the Duke Metabolomics and Proteomics Institute (DMPI) will be required.
• Ongoing engagement with the Food and Drug Administration (FDA) through IND amendments