Clinical Laboratory Director - PO Medical

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Position Overview

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.

Essential Duties

Include, but are not limited to, the following:

• Perform duties of clinical consultant, technical supervisor, general supervisor, and testing personnel, if qualified, as needed, or delegate these responsibilities to qualified personnel, while remaining responsible for ensuring that these delegated duties are properly performed.
• 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, to include, the pre-analytic, analytic, and post-analytic phases of testing:
  • Ensure that test methodologies have the capability of providing the quality of results required for patient care.
  • Ensure validation and verification procedures are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method.
  • Ensure laboratory personnel are performing the test methods as required for accurate and reliable results.
  • 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, including policies and procedures and mechanisms to:
  • Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system.
  • 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.
• As needed, 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 for the RWC Clinical Pathology team.
  • Review submitted pathology reports and materials.
• Provide global pathology product and service support, to include handling consultative calls and leading investigations.
• 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, such as on training Clinical Pathology staff and translating, standardizing, and documenting standard operating procedures (SOPs).
• As requested, 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.

Minimum Skills and Qualifications

• Ability to meet one of the qualifications below:
  • 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, or 1+ years of laboratory training during medical residency; including, but not limited to, 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.

Preferred Qualifications

• Strong molecular experience and/or formal molecular training.
• Completion of a Subspecialty Fellowship.

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.

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