Soni Shukla
Senior Director of Technology Development @Guardant Health
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WORK HISTORY
Senior Director of Technology Development @Guardant Health
Palo Alto, CA, US
Lead product development across Guardant Health’s portfolio with emphasis on advancing oncology diagnostics, including liquid biopsy, tissue-based products, and cancer screening solutions. Responsible for strategy and execution across U.S. and international markets, spanning RUO, LDT, and IVD regulatory pathways. Drive innovation, regulatory success, and global commercialization to ensure impactful diagnostics reach patients and clinicians worldwide.
EDUCATION
The Ohio State University
Genetics
ABOUT SONI SHUKLA
Extensive experience in research and regulated product development across start-ups and large organizations. Strong background in genetics and molecular biology applied to oncology diagnostics, spanning liquid biopsy, tissue-based products, and cancer screening solutions. Expertise includes RUO, LDT, and IVD products under design control and international regulatory frameworks.Proven leader recognized for building and scaling high-performing cross-functional teams, driving global regulatory submissions, and bringing innovative diagnostics from concept to market.Career Highlights:Secured FDA approval for the first diagnostic test combining liquid biopsy with NGS.Directed development of an FDA-approved infectious disease diagnostic targeting antimicrobial-resistant bacteria.Guided product development and lifecycle management of oncology, tissue, and screening products across U.S. and global markets.
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