Dr. Jelena Gradistanac, PhD

Dr. Jelena Gradištanac is a highly respected leader in the clinical laboratory field, known for her deep expertise in laboratory operations, regulatory compliance, and technical oversight. In 2024, she was appointed to the position of Laboratory Director of Sanctus Life Sciences. Two years earlier, she founded JG Lab Services, LLC, a consultancy dedicated to guiding new and existing laboratories through every phase of development—from build-out and design to accreditation and compliance.

In addition to these roles, Dr. Gradištanac also serves as an Off-Site Laboratory Director for Brandywine Urology Consultants and Clariti Diagnostics, where she has been instrumental in modernizing workflows, streamlining testing protocols, and leading laboratories through successful CAP, COLA, and CLIA inspections. Her leadership consistently resulted in elevated quality standards and optimized operational efficiency.

Through her consultancy, Dr. Gradištanac has directed numerous lab start-ups, managing all aspects of development including facility planning, equipment selection, SOP documentation, staff training, informatics integration, and quality management systems. She has transformed startup labs into fully accredited, revenue-generating operations built on scientific rigor and regulatory precision.

As a College of American Pathologists (CAP) Inspector, she conducts on-site inspections and provides hands-on guidance to labs navigating complex accreditation requirements and corrective action planning.

In addition to her operational leadership, Dr. Gradištanac is a recognized thought leader in the field. She has authored peer-reviewed publications, presented at national industry conferences, and mentored over 100 laboratory professionals on topics including assay validation, quality metrics, and regulatory best practices.

Dr. Gradištanac holds a PhD in Biomedical Sciences and is board-certified by the American Board of Bioanalysis (ABB) as a High Complexity Laboratory Director (HCLD) and Technical Supervisor (TS). Her work continues to influence the future of clinical diagnostics through a rare blend of scientific expertise, regulatory mastery, and entrepreneurial vision.