Tomasz Gwozdz
Senior Director Precision Medicine @AstraZeneca
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WORK HISTORY
Senior Director Precision Medicine @AstraZeneca
Cambridge, GB
EDUCATION
Wrocław University of Science and Technology
Master of Science (MSc), Biotechnology
Wrocław University of Science and Technology
Doctor of Philosophy (PhD), Biochemistry and Molecular Biology
SKILLS
ABOUT TOMASZ GWOZDZ
Expert in MDx IVD development and implementation for drug products.SUMMARY OF RELEVANT QUALIFICATIONS:• PhD in Molecular Biology and MSc in Biotechnology • 20+ years of experience in research and MDx IVD development across academia and industry• Diagnostic expert with experience across assay development, implementation and global strategy for drug products• Interactions with regulatory bodies (mainly FDA/EMA) across development stages (e.g. Study Risk Determination (SRD), Investigational Device Exemption (IDE), Premarket Approval (PMA), Postmarket Commitments, etc.)• Diagnostic Team Leader supporting global cross-functional drug product teams• Understanding of clinical trials conduct and testing needs
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