Kathy Tygum Goldstein PharmD, RPh, CCRA

Kathy Goldstein is currently the Sr. Director, Head, Quality Management Lead at Regeneron Pharmaceuticals. In this position, Dr. Goldstein leads a team of Quality Management Leads who ensure quality and compliance for all global clinical study activities. The quality management leadership team is responsible for providing guidance, interpretation, support, training, and key input to clinical study teams on GCP regulations, guidelines, corporate standards, and policies. The team also participates in GCP inspections and leads inspection preparation activities with clinical study teams. Dr. Goldstein has more than 20 years of experience in the biotech, pharmaceutical, and medical device industries, with positions in pharmacokinetics and drug metabolism research, clinical operations, quality and compliance, and project management. Prior to joining Regeneron Pharmaceuticals, she has held quality/compliance roles, along with extensive operational experience as a CRA and clinical program manager where she managed study teams, timelines, and deliverables to ensure the overall success of sponsor programs. Dr. Goldstein holds a B.S. in pharmacy from the University of Minnesota and a doctor of pharmacy from the University of Florida. She has also completed a Pharmacy Practice residency program accredited by the American Society of Health-System Pharmacists (ASHP). Dr. Goldstein has also earned ACRP’s Certified Clinical Research Associate (CCRA) designation.