Clinical Laboratory Director Position

Day Zero Diagnostics is an infectious disease diagnostics company using whole genome sequencing and machine learning to combat the rise of antibiotic-resistant infections. Our first product, EpiXact®, is a rapid turnaround whole genome sequencing and analysis service helping infection control professionals quickly and confidently determine which infections are part of a suspected outbreak.

Day Zero is seeking a part-time Clinical Laboratory Director to help establish a CLIA certified Laboratory for EpiXact and additional High-Complexity Genomics Testing. The Laboratory Director will fulfil the local, state and federal requirements of the CLIA Laboratory Director and Clinical Consultant roles.

Roles and Responsibilities will include:

  • Provide guidance and approval to bring a Research Use Only (RUO) test laboratory to CLIA standards.
  • Provide clinical oversight of the laboratory either remotely or onsite as needed, with availability for consultation by laboratory personnel.
  • Assist with the establishment of policies and procedures for assay validation, clinical implementation, quality control, and quality assessment programs.
  • Participate in state inspection activities and correspondence with appropriate regulators.

Qualifications required:

  • MD, DO, or PhD with American Board of Medical Microbiology (ABMM), American Board of Medical Genetics and Genomics (ABMGG), American Board of Bioanalysis (ABB) or equivalent Board-certification approved by HHS.
  • Licensed in the state of Massachusetts.
  • Must have several years of experience directing a clinical laboratory, preferably with experience in High-complexity Laboratory Testing.
  • Experience in complex molecular diagnostic techniques, including hands-on experience with Next-Generation Sequencing assays and review of metagenomic data analysis.
  • Experience with developing a Quality Management Program for Clinical NGS testing is preferred.
  • Must work effectively with an interdisciplinary team of scientists, physicians, lab technologists.

Part time, 4-8 hours per month.

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