Senior Director, Assay Development

Delfi Diagnostics Inc.
Palo Alto, CA
Job Description
DELFI Diagnostics is developing next-generation, blood-based tests for cancer detection. The Senior Director of Assay Development will lead the development of assays for cancer screening, from study design to regulatory submissions.

Requirements

  • PhD or MS in Molecular Biology, Biochemistry, Biomedical Engineering, Genomics, or a related discipline
  • 12+ years in IVD and/or LDT assay development in regulated environments
  • Hands-on expertise in AV and design verification of multi-marker genomic or ‘omic-based assays
  • Deep knowledge of IVD regulatory frameworks: FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IVDR

Benefits

  • Flexible time-off policy
  • 401(k) retirement plan
  • Competitive medical, dental, and vision coverage
  • Onsite lunch 3 days a week
  • Wellness-related offerings
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