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.
- 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.