Keith Krasnigor
Drug Development Team Leader
- Role
- Global Development Team Leader, Tlx591 at Telix Pharmaceuticals Limited
- Location
- Thousand Oaks, CA, US
- LinkedIn followers
- 500 followers
About Keith Krasnigor
Accomplished professional with a consistent track record in formulating and executing…
Experience
Global Development Team Leader, Tlx591
May 2024 — Present · 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
- Launch Products
- Drug Development
- Market Access
- Biologics
- Oncology
- Nephrology
- Endocrinology
- Pain Management
- Marketing Strategy
- Direct to Consumer
- Matrix Management
- Medical Devices
- Biotechnology
- Clinical Development
- Commercialization
- Global Marketing
- Hematology
- Pharmaceutical Industry
- Life Sciences
- Medical Affairs
- Cross-Functional Team Leadership
- Infectious Diseases
- Lifesciences
- Product Launch
- Strategy
- Biopharmaceuticals
- Pharmaceutical Sales
- Market Analysis
- Management
- Therapeutic Areas
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