Kathleen (Kushner) Mandziuk | Senior Scientific Affairs Director
PRA Late Phase Services

Ms. Kushner’s professional research career has almost exclusively been in the area of late phase development. Following her nursing training, she joined the pharmaceutical industry as a Clinical Data Coordinator and enjoyed a variety of management positions in the late phase group of another large CRO. In these roles, she managed the data aspects of several large global post-approval and biomarker/diagnostic projects from planning to analysis. Her responsibilities included overall strategic planning, daily operational supervision, upper management communications, and mentoring activities to several departments/units. Following her success in Data Management, Ms. Kushner transitioned into a Project Manager position and was responsible for the overall management of post-approval projects specializing in large national and international post-marketing and registry programs. She managed several programs ranging in size from 60 - 18,000 patients in a number of countries (US, Canada, Europe, Central/South America, and Asia) and therapeutic areas (CNS, dermatology, GI, ophthalmology, men’s health and oncology). Prior to joining PRA Late Phase Services, Ms. Kushner worked as a Project Manager at a company dedicated to strategic design and implementation of late phase studies where she directed all operational aspects of late phase programs that included clinical operations, data management, pharmacovigilance, biometrics, and external vendors (including claims databases).