ABOUT US:  Biodesix is a leading diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat® targeted ddPCR™ test, the GeneStrat NGS® test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an average of two to three business days, expediting the time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, please visit www.biodesix.com.    OVERVIEW:  The VP, Lab Operations will be primarily accountable for day-to-day Laboratory Operations in the Biodesix Louisville, CO Laboratory and provides oversight of the business and technical/operational functions of the clinical testing Laboratory. Business functions include staffing in support of IQ Lung, Biopharma clinical trials, and Diagnostic services. Technical and operational support includes partnering with internal teams on quality and regulatory compliance management, vendor and audit support. Key responsibilities include technical readiness and personnel support for new Product Development services and technology transfer from R&D into the Clinical Laboratory.   It is highly desired that this on-site clinical laboratory Leadership role includes fulfilling the Technical Supervisor responsibilities for all CLEP/CAP/CLIA licensed laboratory clinical testing activities from sample receipt through result generation, product improvement planning and report development through approval, production planning, and oversight to the development of new diagnostic tests. This role is accountable for ensuring personnel technical training, CE compliance, site planning, hiring, and on-boarding in collaboration with the relevant cross-functional teams in the Biodesix Corporate Clinical Laboratory in Louisville, CO.   JOB LOCATION:  Louisville, CO | On-Site  RESPONSIBILITIES:  Either directly, or by delegation shall be responsible for: Supervision of all services and procedures performed by the Laboratory Operations or Development team located in the Corporate laboratory Development and maintenance of procedures and protocols, including product and service improvements to assure the compliant function of the laboratory Supporting the preparation and filing of reports of all development and testing procedures performed by the laboratory Participate in the development and refinement of product and service requirements, implementation of test development within laboratory operations, including but not limited to the improvements, LIMS, test ordering and test report delivery, vendor selection and qualification Draft, review, edit and complete study plans and technical documents (validation studies) required for various stages of feasibility, development, improvement and for regulatory submissions Participation in Quality review meetings, including in Lab Action Board (LAB) and Quality Review Board (QRB) meetings Participation in opening and closing meetings with regulatory/quality agencies Provide External Development client and other academic and medical collaborators consultative support (as required) Perform all duties of a laboratory Technical Supervisor as required by applicable laws, regulations, and accreditation standards Contributes to Laboratory planning, budgets and forecasting Contributes to planning and dissemination of company goals and objectives; for example, in clinical study design, new product development, strategic partnerships/collaborations, technology roadmap, publications and presentations Executes efficiently against the overall goals of the company; for example, communication across departments regarding the status and challenges in the laboratory operation function Presents at key scientific conferences in support of company objectives; examples include annual meetings of AACR, ASCO, AMP, ADLM, MSACL, ASMS as needed REQUIREMENTS: Demonstrated capability to mentor and develop junior team members is strongly desired Record of accomplishment in managing Laboratory Operations in a clinical reference laboratory or pharmaceutical testing environment Training in performing biological assays utilizing analytical chemistry and biochemical approaches Experienced in proteomics tests with a focus on applications for the clinic Experience establishing and managing a high complexity diagnostics laboratory Experience managing all aspects of a laboratory, including budgets, organization Demonstrated experience of compliance with CAP/CLIA certification, ISO13485 requirements as well as US state laboratory licensures and accreditations Experience managing, motivating, and mentoring staff, directing laboratory personnel to develop skills necessary for performing operations in a diagnostics laboratory Experience directing the daily operations of a high-complexity testing CAP/CLIA accredited testing laboratory A background of ensuring departmental compliance with all Regulatory, Quality and other FDA regulations Ongoing training will be provided to supplement key skills required to perform the functions of this position as applicable EDUCATION & EXPERIENCE:  PhD, MD. Must have 10 years+ of post-graduate experience with significant regulatory interactions. Must have previous experience gaining and maintaining CLIA, CAP and other laboratory certification as required for the continuing operations of the Biodesix laboratories Eight or more years of laboratory operations experience at a senior level, with demonstrated abilities in mentoring and developing technical talent, scaling operations and managing costs. COMPENSATION:  Annual Base Compensation starting at $173,000 Discretionary Bonus opportunity  Comprehensive health coverage: Medical, Dental, and Vision  Insurance: Short/Long Term Disability and Life Insurance  Financial benefits: 401(k), Flex Spending Account  120 hours of annual vacation  72 hours of paid sick time off   11 paid holidays + 3 floating holidays  Employee Assistance Program  Voluntary Benefits  Employee recognition program  Individual base compensation is based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related aspects.    Biodesix is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.