Laboratory Medical Director

    • Phoenix, AZ

Summary of Major Responsibilities

Exact Sciences is seeking an extraordinary Molecular Pathologist with a strong interest in Precision Medicine to be the Laboratory Medical Director at the Exact Sciences Clinical Laboratory in Phoenix.  The Laboratory Medical Director has primary accountability for ensuring that best in class gene mutation panel test results provided by the Phoenix Clinical Laboratory are accurate, timely, and appropriately supported with medical consultancy to ordering physicians and their patients.  They are accountable for ensuring that all tests offered by the Clinical Laboratory are appropriately analytically and clinically validated, and that all aspects of pre-analytical, analytical, and post-analytical laboratory services are provided in compliance with a well-documented Quality Management System (QMS) that meets all applicable regulatory requirements and quality standards.  The Laboratory Medical Director will be a functional manager and will assist in providing best in class Anatomic, Clinical, and Molecular Pathology services while directly managing internal and consulting pathologists conducting these services for the Clinical Laboratory. 

Essential Duties and Responsibilities

  • Ensure that test results provided by the Clinical Laboratory are accurate, timely, and provide clinical utility to ordering physicians and their patients.
  • Provide best in class customer support to ordering physicians, pathologists and patients.
  • Ensure that the Clinical Laboratory maintains an effective Quality Management System for all pre-analytical, analytical, and post-analytical services which meets all applicable state, federal, and international regulatory requirements and quality standards.
  • Review and approve all standard operating procedures (SOPs) within the scope of the Clinical Laboratory’s QMS to ensure that they are clear, accurate, and complete.
  • Provide guidance on methodology for assay development, validation, and operationalization, and ongoing performance monitoring of Clinical Laboratory tests, including those based on immunohistochemistry (IHC), next-generation sequencing (NGS), and other methods.
  • Ensure that scientific, clinical, quality, and regulatory requirements are met for analytical and clinical validation of the Clinical Laboratory tests through review and approval of the associated study protocols and reports.
  • Perform and oversee Anatomic, Clinical, and Molecular Pathology services as required for results generation, test report creation and delivery of test results, including annotation, review, interpretation, sign out.
  • Perform and oversee molecular tumor board and internal consultation services including review and interpretation of associated pathology reports, interpretation of H&E and IHC stained tissue specimens, DNA and/or RNA sequencing results, other Clinical Laboratory results and clinical pathology correlation.
  • Ensure the scientific and clinical rigor of all proposed rules for use in the Clinical Laboratory’s “rules engine”, which defines how specific gene variants and IHC results are interpreted on the Clinical Laboratory’s patient reports; review and approve all proposed rules based on the evidence supporting these.
  • Ensure that an appropriately rigorous, scalable documented process is followed for review and sign out of all clinical test reports.
  • If qualified, perform duties of Clinical Consultant, Technical Supervisor, General Supervisor, and Testing Personnel as needed or delegate these responsibilities to qualified personnel, while remaining responsible for ensuring that these delegated duties are properly performed.
  • Remain accessible to laboratory to provide on-site, telephone, or electronic consultation as needed.
  • Ensure laboratory conditions are appropriate for testing performed and provide a safe environment in which employees are protected from hazards.
  • Ensure personnel have the required education and laboratory experience and are appropriately trained, competent, and performing test methods as required for accurate and reliable results.
  • Ensure that the laboratory has an appropriate proficiency testing program and that proficiency samples are tested as required, results are returned within the expected timeframes, reports are reviewed to evaluate laboratory’s performance, and corrective action plans are followed if proficiency testing specifications are not met.
  • Ensure that quality control and assurance programs are established and maintained.
  • Ensure that patient test results are reported only when the test system is functioning properly and that remedial actions are taken and documented whenever significant deviations from established performance are identified.
  • Ensure that test result reports include pertinent information required for interpretation.
  • Ensure that consultation is available to clients on the quality of test results and their interpretation.
  • Employ and appropriately supervise a sufficient number of laboratory personnel with appropriate education, experience, and training to accurately perform tests and report results.
  • Ensure that policies and procedures are established for monitoring individuals who conduct any phase of testing (pre-analytic, analytic or post-analytic), to assure they are competent and maintain their competency, and to identify needs for remedial training and continuing education to improve skills.
  • Specify, in writing, the responsibilities and duties of each consultant and supervisor, as well as each person engaged in all phases of testing and identify which examinations each individual is authorized to perform, whether supervision is required, and whether supervisory or Lab Director review is required before reporting test results.
  • The Laboratory Medical Director may not delegate the following responsibilities:
    • Ensure quality services for all aspects of service.
    • Ensure safe and adequate environmental conditions.
    • Ensure Laboratory Director-approved procedures are available to staff.
    • Ensure sufficient number of employees with appropriate education/training.
    • Provide position descriptions for Clinical Consultant, Technical Supervisor.
    • Ensure all delegated Laboratory Director duties are properly performed.
    • Ensure regulatory requirements for supervision of testing personnel are met.
    • Ensure test performance only within the limitations of the clinical laboratory license.
  • Excellent written and verbal communication skills to convey difficult information in a clear, kind, and respectful manner.
  • Willingness and ability to work in and contribute to a fast-paced, highly collaborative environment.
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
  • Support and comply with the company’s Quality Management System policies and procedures.
  • Regular and reliable attendance.
  • Standing or sitting for long periods of time may be necessary.
  • Some lifting (greater than 25 pounds) may be necessary.
  • Considerable amount of time using various types of laboratory equipment including microscopes, microtomes, blades, strainers, pipettes.
  • May perform repetitious actions using lab tools.
  • Some time spent using near vision to view samples at close range.
  • Use of various chemicals may be used to perform duties.
  • Use of computer and some time may be spent concentrating, reading, or analyzing data, or applying scientific rules.
  • May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
  • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for up to approximately 90% of a typical working day.
  • Ability and means to travel between (either Madison or Redwood City) locations.
  • Ability to travel approximately 10% of working time away from work location, may include overnight/weekend travel.

Qualifications

Minimum Qualifications

  • MD degree with certification in Anatomical, Clinical, and/or Molecular Pathology.
  • Possession of Arizona Medical License at time of hire and maintain throughout employment in position.
  • Possession of or eligibility for New York Certificate of Qualification in all disciplines relevant to the Clinical Laboratory’s current and planned tests at time of hire or obtain within 3 months of hire and maintain throughout employment in position.
  • 5+ years of combined experience and knowledge in the following:
    • somatic variant classification and functional interpretation of somatic variants according to established professional guidelines (e.g., AMP or ESMO).
    • professional guidelines for the diagnosis or treatment of cancer, as published by NCCN, ESMO, ASCO or WHO.
    • molecular laboratory technology and operations, regulatory requirements, and professional guidelines.
    • cell free DNA, solid tissue, and/or next-generation sequencing based assays and assay validation.
  • Authorization to work in the United States without sponsorship.
  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

  • Professional society memberships preferred including CAP, AMP, ASCO, USCAP.

This is a field based role.

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EEO Disclosure

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.


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