Kris Gambelin is a Senior Director of Clinical Operations who brings over 20 years of Clinical and Regulatory expertise to LENZ Therapeutics, ten of which were in the ophthalmic space at VISX, Incorporated. Her experience conducting all stages of clinical trials (first-in-human through pivotal) demonstrates a proven track record of guiding a product from inception through approval. She will be a critical team player in ensuring the success of our pivotal Phase 3 clinical trial.
Prior to LENZ, Kris spent the past ten years as an independent consultant for multiple medical device companies in the sleep apnea, emphysema, migraine, weight loss, surgical instrument, and dialysis space. Before branching off as a consultant, she was the Director of Clinical and Regulatory Affairs at VISX, Incorporated. Over the combined twenty years, she has experience managing multiple non-significant risk and IDE trials and brings a wide range of experiences to the clinical trial process. Kris has been actively involved in the development of clinical protocols, facilitated investigator relations, conducted study initiation meetings, negotiated contracts and managed Contract Research Organizations. Kris also has experience in Regulatory Affairs conducting clinical data analysis, drafting labeling materials, conducting CER updates including literature searches and assessment of complaints, and has assisted in the preparation and submission of multiple 510(k)’s and IDEs for class II and class III medical devices, which resulted in IDE approval and FDA clearance. Kris has direct experience interfacing with the FDA to facilitate responses to deficiencies and labeling changes resulting in FDA approval of 5 PMA supplements and 2 IDEs. Kris has a Bachelor of Science from Santa Clara University.