Sr. Writer and Manager
Kelly Kilibarda joined Whitsell Innovations (WI) in 2013 and was promoted to Medical Writing Services (MWS) Manager in 2021. In addition to providing project management and team leadership, she writes clinical research and regulatory documents for the US Food and Drug Administration, the European Medicines Agency, and for submission to other regulatory agencies.
Dr. Kilibarda’s area of expertise is oncology, but she also has experience in the therapeutic areas of infectious disease (antibacterial, antiviral, antifungal, and antiparasitic), hematology, reproductive health/endocrinology, metabolic disorders, rare disease, neurology, nutrition/dietary supplements, asthma, and surgery. In addition to regulatory documents, Dr. Kilibarda authors publications, white papers, monographs, and educational modules. She also leads in-house training sessions on regulatory and medical writing and has mentored interns and writers at WI.
Prior to joining WI, Dr. Kilibarda was a postdoctoral researcher in the Department of Pathology at Duke University. Her postdoctoral research focused on chemoresistance in triple-negative breast cancer. Dr. Kilibarda received her PhD in Pathology from Duke University in 2013, where she was supported by a predoctoral fellowship from the Department of Defense. In her graduate research, Dr. Kilibarda studied the role of monocarboxylate transporters in lactate metabolism in cancer cell lines. During her graduate studies, she maintained radiation safety records for the research laboratory and helped with radiation safety compliance. Prior to graduate school, Dr. Kilibarda worked as a Gross Room assistant for Pathologists and Pathologist Assistants and was certified in 2005 as a Medical Technologist/Clinical Laboratory Scientist by the American Society for Clinical Pathology after completing clinical rotations in hematology, clinical chemistry, microbiology, immunology, phlebotomy, and blood bank at Lancaster General College of Nursing and Health Sciences and Lancaster General Hospital. Dr. Kilibarda received a Bachelor of Science in biology, with a minor in English, from Millersville University.