POSTDOCTORAL ASSOCIATE

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.

Post-Doctoral Research Fellow Outline 2025-26 

Purpose: The primary focus of this role will be to oversee clinical translation of a novel EGFRvIII x CD3 bi-specific T cell engager for the treatment of glioblastoma. Additionally, research support will be required for ongoing tissue-based trials being conducted within the Khasraw lab. Duties include: 

· 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. 

Post-opening of the trial, oversight of biomarker collection and analysis pertaining to pharmacokinetics, anti-drug antibodies and cytokine release will be necessary. Oversight of sample processing and method development with multiple contract research organizations relating to toxicity, ADA and sample storage/labelling/stability studies will also be key responsibilities. Preliminary work pertaining to developing a Working Cell Bank along with potential further cGMP manufacturing runs will also form part of the responsibilities of this role. 

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 

Preferred 

· Experience with bi-specific T cell engager therapy. 

· Experience with regulatory filings and communications with the FDA.

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