About UsOur mission is to cure cancer through high performance, accessible early cancer detection. That means saving lives. Delfi Diagnostics is a Johns Hopkins spinoff focused on the non-invasive detection of cancer at earlier stages, when it is most curable. DELFI uses artificial intelligence and whole genome sequencing to detect unique patterns of DNA fragmentation in the blood of patients with cancer. These analyses are performed through simultaneous examination of millions of DNA sequences using machine learning to identify tumor-specific abnormalities.In our passionate pursuit to radically improve health outcomes, we serve humanity when we:Lead with Science, Anchor in Pragmatism: We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction. Build With & For All: We embrace diverse backgrounds to innovate and achieve together. We are not just building a product - we aim to disrupt the path of cancer for all - no matter geography or socioeconomic class Put We over I: We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us--win. We show up with empathy, humility, and integrity at every step of the journey.What you’ll do● Regularly participate in cross-functional, Laboratory Developed Test (LDT) developmentplanning efforts with Tech Dev, Commercial, Data Science, Quality and Software Systems toensure that CAP/CLIA/NYS requirements are addressed and understood; provide technical,scientific, and medical contributions to these product development teams● Provide clinical and scientific input regarding the planning and execution of Analytic and ClinicalValidation studies● Work with Regulatory, Commercial, and Research & Development teams to plan for and obtainFDA approval of diagnostic tests● Work with Commercial, Clinical, and Reimbursement teams to obtain Clinical Utility data● Ensure that the testing systems developed and used for each test performed in the laboratoryprovide quality laboratory services for all aspects of test performance, which includes the pre-analytic, analytic, and post-analytic phases of testing● Ensure that all Clinical Laboratory duties are properly performed● Be accessible to the Clinical Laboratory in Palo Alto, CA to provide onsite, telephone orelectronic consultation as needed● Ensure that the Clinical Laboratory participates in a suitable accuracy assessment (proficiencytesting) program● Ensure that the quality control and quality assessment programs are established andmaintained to assure the quality of Clinical Laboratory services provided● Consult with the Clinical Laboratory's clients on matters relating to the quality of the testresults reported and their interpretation concerning specific patient conditionsWhat you’ll have accomplished twelve months from now● Identified and generated requirements for new laboratory developed tests, up to and includingthe launch of these novel tests under CAP, CLIA, and NYS LDT requirements● Partnered with our functional teams (e.g., laboratory operations, research and development,clinical, quality and regulatory, etc.) accordingly● Augmented our current CAP/CLIA laboratory program with your passion and ideas● Assisted with the continued build-out and expansion of our Palo Alto, CA laboratory● Facilitated and supported the achievement of key corporate goalsWhat you'll bring to Delfi● The successful Laboratory Director for this role will be collaborative and exhibit scientific curiosity, especially as applied to development and scientific understanding of molecular-baseddiagnostic tests. The individual will communicate clearly and engage with diverse scientific and clinical colleagues within, and external to, the Delfi organization. The Candidate will have, or will develop, a deep understanding of CLIA, CAP, and NYS regulations, and will exercise his/her authority based on this knowledge. Candidate understands that they are ultimately responsible for all diagnostic testing results and so must have a deep commitment to patient care.● Must be a Doctor of Medicine or Doctor of Osteopathy licensed to practice medicine orosteopathy in the State of California; and● Must be certified in Anatomic or Clinical Pathology, or both, by the American Board ofPathology or American Osteopathic Board of Pathology or possess qualifications that areequivalent to thoserequired for such certification;OR● Be a Doctor of Medicine, or a Doctor of Osteopathy licensed to practice medicine, orosteopathy in the State of California; and● Have at least one year of laboratory training during medical residency (for example, physicianscertified either in hematology or hematology and medical oncology by the American Board ofInternal Medicine); or● Have at least 2 years of experience directing or supervising high complexity testing;OR● Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory sciencefrom an accredited institution; and● Be certified and continue to be certified by a board approved by HHS; and● Be licensed as a Laboratory Director by the State of CaliforniaAn equal opportunity employerWe are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.