Kimberley Buytaert-Hoefen

Kimberley Buytaert-Hoefen, Ph.D., is a distinguished regulatory affairs executive with over 25 years of experience in global regulatory strategy, clinical trial oversight, and quality compliance, with a strong focus on gene and cell therapy. She holds a Ph.D. and M.A. in Behavioral Neuroscience from the University of Colorado at Boulder and a B.A. in Psychology from Binghamton University.

Dr. Buytaert-Hoefen’s expertise spans stem cell research, regenerative medicine, and translational science, including postdoctoral work in medical oncology and clinical pharmacology. Her leadership experience includes roles such as Executive Director and Global Head of Regulatory Affairs at QPS Holdings LLC, Director of Regulatory Affairs at Azzur Group, and Principal Consultant at Parexel, where she led global regulatory strategies for advanced therapies and major submissions including INDs, BLAs, and MAAs. Earlier in her career, she served as an FDA Field Investigator, ensuring compliance across pharmaceutical and medical device sectors.

As Chief Operating Officer at Pearl Pathways, Dr. Buytaert-Hoefen leads operational strategy, regulatory excellence, and business growth. She is passionate about accelerating life science product development and is committed to expanding the organization’s regulatory, quality, and clinical capabilities in collaboration with the Pearl Pathways and Versiti Clinical Trials teams—ensuring innovative therapies and medical technologies reach patients faster.