Keith Krasnigor
Global Development Team Leader, Tlx591 @Telix Pharmaceuticals Limited
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WORK HISTORY
Global Development Team Leader, Tlx591 @Telix Pharmaceuticals Limited
Thousand Oaks, CA, US
Team leader for a global P3 radiopharmaceutical, 177Lu-TLX591, targeting metastatic prostate cancer with overall development responsibility across CMC, regulatory, clinical operations, clinical development and project management - Responsible for driving critical regulatory milestones including EU-CTR, Japan PMDA and ROW IND preparations overseeing regulatory sub teams with cross-functional support- Successfully gained FDA alignment for key P3 endpoint priority, statistical plan and CMC amendments to support Part 2 of the P3 study in preparation for commercialization globally
EDUCATION
Colby College
Bachelor of Arts (BA)
SKILLS
ABOUT KEITH KRASNIGOR
Accomplished professional with a consistent track record in formulating and executing…
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