Clinical Laboratory Director - PreventionGenetics

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At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.

Position Overview

The Clinical Laboratory Director is responsible for the overall operation and administration of the Clinical Laboratory as well as serving as a subject matter 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 ensuring all tests meet medical, professional and regulatory performance standards, providing medical expertise in the assessment of patient materials, supporting physicians regarding patient results and laboratory processes, ensuring qualified, well-trained and competent staff, and  ensuring effective investigation and resolution to incidents.  The Clinical Laboratory Director will participate in the Quality Management System, ensuring personnel, test performance/design, test procedures, equipment and facilities support the highest possible medical and operational quality.  The Clinical Laboratory director will work closely with cross-functional team members including Laboratory Operations (pre-analytic, analytic and post-analytic), Laboratory Medical and Pathology, Customer Service, Product/commercial, Quality, Systems Engineering, Information Technology, and Facilities in the improvement and development of new processes and technologies.  

Essential Duties

Include, but are not limited to, the following:

• Perform or delegate duties of clinical consultant, technical supervisor, general supervisor, and testing personnel, while remaining responsible for ensuring that these delegated duties are properly performed. 
  • Identify and delegate appropriate roles to additional individuals based on expertise and staffing needs for the test system and laboratory 
  • Ensure individuals are qualified, trained and competent for their delegated roles 
  • Ensure appropriate delegations, training programs, and qualification criteria exist 
  • Ensure collaborative, effective and mutually supportive team by ensuring training and accountability of delegates 
  • Coordinate and collaborate across teams to support effective communications and procedural frameworks 
• Ensure test performance requirements are established that meet regulatory and medical performance standards 
  • Ensure appropriate test performance characteristics are defined 
  • Ensure medical and technical performance characteristics are evaluated against current regulatory and medical standards and best practices  
• Ensure that the testing systems developed and used for each test performed in the laboratory meet or exceed established test performance requirements, 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. 
  • Liaise with (or delegate appropriately) R&D, product and software teams to provide performance requirements, validation design and requirements that meet regulatory and medical best practices and standards 
  • Ensure validation and verification procedures are adequate to determine the accuracy, precision, and other pertinent performance characteristics established for the test. 
  • 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. 
• 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, monitoring and review 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. 
  • Support and ensure incident investigation, corrective and preventive action 
• Collaborate with cross-functional partners on efforts during new product commercial launches, such as on training, documenting standard operating procedures (SOPs), reviewing marketing materials, etc. 
• As r