Laboratory Director - Part Time
Xilis
Durham, NC, USA
Posted on Feb 18, 2025
Xilis, Inc. is an innovation-driven biotech company developing its proprietary MicroOrganoSphere (“MOS”) Technology for functional precision oncology. Xilis’ MOS Technology enables rapid and scalable generation of patient tumor models that retain patient-specific tumor biology and tumor microenvironment, representing one of the most translationally-relevant ex vivo technologies for precision oncology drug discovery and development. Located in Research Triangle Park, Durham, NC, Xilis is building a functional precision medicine platform that incorporates scaled multi-modal profiling of therapeutic activity and AI/ML-enabled analytics to catalyze functional precision medicine drug discovery, development and diagnostics. Collectively, Xilis aims to harness its MOS Platform to enable development of the most effective therapeutics and guide them to the right patients at the right time.
The Laboratory Director (Part Time) is responsible for ensuring the delivery of high-quality clinical laboratory services. This position will serve as the CLIA Laboratory Director and be listed on the CLIA license. Key responsibilities include functional cellular and molecular assay interpretation and sign-out, assay development and validation, laboratory operations oversight, and advancing Xilis platform capabilities.
Responsibilities
- Provide guidance on the establishment of Xilis’ CLIA laboratory
- Provide strategies to ensure assay compliance with CLIA, CAP, NYS, and applicable state regulations, including North Carolina licensure requirements
- Provide oversight of laboratory operations, ensuring high-quality testing and accurate result reporting
- Review and approve standard operating procedures (SOPs), validation studies, and quality control measures
- Participate in quality management activities, including audits, corrective action plans, and the development of proficiency testing programs
- Review and interpret laboratory test results, providing clinical correlation and guidance as needed
- Ensure ongoing competency assessment and training for laboratory personnel.
- Advise on laboratory expansion efforts, including the implementation of new assays and technologies.
- Serve as the primary liaison with regulatory bodies and ensure successful accreditation inspections
- Provide advice to referring physicians regarding the significance of laboratory findings and ensure that reports of test results include pertinent information required for specific patient interpretation
- Effectively implement a plan of correction for deficiencies identified
- Contribute to, review, and approve laboratory documentation such as policies and procedures, validation plans and reports, training and competency assessments, reagent/control/instrument qualifications, quality audits, deviation approval requests, and nonconforming event reports
Requirement
- Must meet CLIA requirements for a high-complexity laboratory director
- Be a physician who is currently certified by the American Board of Pathology in Anatomic Pathology and Clinical Pathology, and preferably in an area of special competence relevant to oncology and cell-based assays
- Experience with cell-based assays and oncology-related testing preferred
- Strong understanding of CLIA, CAP, and state regulatory requirements
- Ability to commit to a part-time schedule, with flexible availability for oversight and regulatory responsibilities
- Candidates local to RTP or easily able to travel onsite are preferred
Xilis was created when its three founders — an engineer, a physician, and a biologist — decided to come together and commercialize their technology to transform cancer care. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We do not discriminate on the basis of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. Furthermore, even if your work experience isn't perfectly aligned with what we've described above, if you're excited about what we're building then we want to talk to you!
Xilis offers comprehensive health, vision, dental & retirement plans, and unlimited PTO. We are a remote-friendly team: our headquarters are in Durham, North Carolina, but we have team members across the US (and beyond!).