Kristin Neff is a clinical operations and project management expert with over 20 years of leadership and operations experience in the drug and medical device development industry. For much of her career, Kristin has held leadership positions at several growing biotech companies where she built clinical operations departments from the ground up to support evolving novel investigational product development.
Most recently, Kristin served as the Vice President of Clinical Operations at Venthera, a BridgeBio company, developing a novel PI3K inhibitor to treat vascular malformations. Prior to that, Kristin led the ImmusanT Clinical Operations team in development of their epitope-specific immunotherapy to restore immune tolerance in celiac disease patients.
Prior to ImmusanT, at InVivo Therapeutics, Kristin lead their novel investigational product, a bioresorbable polymer medical device to treat acute spinal cord injury, into the clinic through the early feasibility phase and into the pivotal phase of development. Kristin has also held leadership positions in clinical operations project management at ConforMIS, TARIS Biomedical, HeartWare, Boston Scientific, and Vertex Pharmaceuticals where she managed multiple unique development programs across a variety of therapeutic areas with teams both small and large. In addition to clinical operations, Kristin’s experience extends to regulatory operations and quality systems development as well as significant vendor management to ensure successful outcomes. Kristin began her career in the industry at PAREXEL International in project management and data management roles of increasing responsibility.
Kristin has a bachelor of science degree in electrical engineering from University of Massachusetts/Amherst, where she graduated with honors, and a master’s degree in biomedical engineering from Boston University. Kristin conducted graduate research at the Floating Hospital for Children in mechanical modeling of pulmonary function testing in infants and at the NeuroMuscular Research Center.