Vice President of Clinical Operations: Reporting to the COO and 4th employee of the company, built a clinical operations team and led re-design, enrollment and completion of the pivotal (IDE) trial of the Jada System for abnormal postpartum uterine bleeding and hemorrhage. Strategic leadership for all U.S. and O.U.S. clinical operations. In this role Kathryn has;
• Led 15-center US pre-market pivotal IDE study, enrolling the maximum of 107 subjects in a challenging recruitment setting. Developed site relationships, negotiated favorable study contracts and budgets with each site, led training program that certified over 700 site team members as investigators and research staff, drove enrollment programs that approached >16,000 patients and secured informed consent from >7,000 in under 15 months.
• Built clinical study team from 0 to maximum of 6 team members including the roles of Director, Prof Ed Manager, In-house, Field-based and Contract CRAs and Clinical Coordinator. Recruited key talent to executive and adjacent teams.
• Designed and executed “Continued Access” program to ensure extended data collection after close of pivotal study, including successful FDA approval of IDE.
• Presented Clinical Operations updates to quarterly BOD Meetings and investor presentations.
• Developed relationships and key interactions with OB/GYN and Maternal Fetal Medicine specialist KOLs for understanding and advancement of the Jada System.
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