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Clinical Laboratory Director

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Exact Sciences

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Location:
United States , Madison

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Contract Type:
Not provided

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Salary:

227000.00 - 385000.00 USD / Year

Job Description:

The Clinical Laboratory Director is responsible for the overall operation and administration of the Clinical Laboratory as well as serving as a pathology expert. These responsibilities include, but are not limited to, holding the CLIA license for the clinical laboratory and supporting and/or delegating as appropriate all duties established under those requirements (see below) as well as reviewing tissue sent in for commercial assays, providing medical expertise in the assessment of patient materials, supporting physicians regarding patient results and laboratory processes, training the Clinical Pathology staff, and reviewing Clinical Pathology analytics. The Clinical Laboratory Director will participate in the Quality Management System, ensuring personnel, test performance/design, test procedures, equipment and facilities support prompt, accurate, and compliant test results. The Clinical Laboratory director will work closely with cross-functional team members including Laboratory Operations, Laboratory Medical and Pathology, Histology, Customer Service, Analytical Laboratory, Quality, Systems Engineering, Information Technology, and Facilities in the improvement and development of new processes and technologies to ensure the quality and timeliness with which patient samples are processed to ensure highest possible medical and operational quality.

Job Responsibility:

  • Responsible for the overall operation and administration of the Clinical Laboratory as well as serving as a pathology expert
  • Hold the CLIA license for the clinical laboratory
  • Support and/or delegate as appropriate all duties established under CLIA requirements
  • Review tissue sent in for commercial assays
  • Provide medical expertise in the assessment of patient materials
  • Support physicians regarding patient results and laboratory processes
  • Train the Clinical Pathology staff
  • Review Clinical Pathology analytics
  • Participate in the Quality Management System
  • Work closely with cross-functional team members in the improvement and development of new processes and technologies
  • Perform duties of clinical consultant, technical supervisor, general supervisor, and testing personnel, if qualified, as needed, or delegate these responsibilities to qualified personnel
  • Ensure that the testing systems developed and used for each test performed in the laboratory provide quality laboratory services for all aspects of test performance
  • Ensure that test methodologies have the capability of providing the quality of results required for patient care
  • Ensure validation and verification procedures are adequate
  • Ensure laboratory personnel are performing the test methods as required
  • Ensure that the laboratory has an appropriate proficiency testing program
  • Ensure appropriate delegations, training programs and qualification criteria
  • Collaborate with the quality team to ensure effective quality control and assurance programs are established and maintained
  • Ensure the establishment and maintenance of acceptable levels of analytical performance
  • Ensure that patient test results are reported only when the test system is functioning properly
  • Ensure that test result reports include pertinent information required for interpretation
  • Perform/oversee expert microscopic review of clinical laboratory H&E and IHC slides
  • Act as a critical resource for complex case H&E and IHC review
  • Review submitted pathology reports and materials
  • Provide global pathology product and service support
  • Review quarterly metrics
  • Provide consultative services to Customer Service, Commercial, and Medical Affairs
  • Collaborate with cross-functional partners on efforts during new product commercial launches
  • Provide input in the development of educational slide decks, sales materials, speaker events, Speaker Training Programs, and Advisory Boards
  • Lead and/or participate in Clinical Pathology process improvements

Requirements:

  • Possession of Anatomic Pathology or Anatomic and Clinical Pathology certification by the American Board of Pathology or American Osteopathic Board of Pathology at time of hire and maintain throughout employment in position
  • 1+ years of laboratory training during medical residency
  • physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine and 2+ years of experience directing or supervising high complexity testing, in lieu of certification
  • Demonstrated expertise in molecular techniques and applications
  • Experience/ability to support high throughput laboratory processes
  • Experience leading teams, projects, and/or committees with a demonstrated ability to lead through influence
  • Excellent communication skills
  • Excellent analytical, critical thinking and risk management skills
  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation
  • Authorization to work in the United States without sponsorship
  • Ability to comply with any applicable personal protective equipment requirements
  • Ability to use near vision to view samples at close range
  • Ability to travel 5% of working time away from work location, may include overnight/weekend travel
  • Ability to lift up to 15 pounds for approximately 5% of a typical working day
  • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 80% of a typical working day
  • Apply excellent written and verbal communication skills to convey difficult information in a clear, kind, and respectful manner
  • 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
  • Maintain regular and reliable attendance

Nice to have:

  • Strong molecular experience and/or formal molecular training
  • Completion of a Subspecialty Fellowship
What we offer:
  • Paid time off (including days for vacation, holidays, volunteering, and personal time)
  • Paid leave for parents and caregivers
  • A retirement savings plan
  • Wellness support
  • Health benefits including medical, prescription drug, dental, and vision coverage
  • Bonus eligibility

Additional Information:

Job Posted:
February 18, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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