Julie Ann Mayer
Strategic Operations and R&D Leader | Translational Research | Companion Diagnostics | Scientific Consulting
- Role
- Vice President Global Biomarker Platform at Crown Bioscience
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Julie Ann Mayer
Dynamic leader with proven success in scaling high-complexity clinical laboratory operations and optimizing workflows to increase efficiency, quality, and scalability. • Experienced in leading diverse teams of 100+ professionals through continuous improvement, strategic execution, and operational transformation. • Extensive background in assay and product development, including validation and CLIA transfer of over 50 biomarker assays across multiple CLIA/CAP-accredited laboratories. • Directed cross-functional R&D initiatives that supported key regulatory milestones such as FDA CDx approvals, PMA and BLA submissions, as well as multiple 510(k), MolDx, and NYSDOH filings.• Highly skilled in bridging science and strategy through data-driven decision-making, innovative process design, and collaborative leadership. Deep expertise in regulatory frameworks (FDA, GCP, GMP, CAP, CLIA) and a strong foundation in business operations, compliance, and strategic growth execution.
Experience
Vice President Global Biomarker Platform
Dec 2023 — Present · San Diego, CA, US
Education
University of California, Riverside
BS, Biology
Keck School of Medicine of the University of Southern California
MS, Experimental and Molecular Pathology
Keck School of Medicine of the University of Southern California
PhD, Pathology
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