L. Mary Smith, Ph.D. is a biotechnology executive with nearly three decades of experience leading drug development and advancing innovative therapies across oncology, immunotherapy, gene therapy, and rare diseases. She currently serves as Chief Operating Officer of R1 Therapeutics, where she leads operational and development strategy to advance novel therapies for patients with chronic kidney disease. Dr. Smith also serves on the Board of Directors of Lifordi Immunotherapeutics.

Previously, Dr. Smith was Chief Development Officer at SpringWorks Therapeutics, where she led the development of nirogacestat, approved in 2023 for the treatment of desmoid tumors, and mirdametinib for neurofibromatosis. Earlier in her career at United Therapeutics, she played a key leadership role in the development and approval of Unituxin®, the first immunotherapy approved for high-risk neuroblastoma in the United States and Europe.

Dr. Smith has extensive experience leading multidisciplinary development organizations spanning clinical development, regulatory strategy, biometrics, clinical pharmacology, CMC, and quality, guiding numerous programs from early development through regulatory approval. She earned her Ph.D. in Microbiology from the University of New Hampshire and has authored numerous peer-reviewed scientific publications.