Clinical Laboratory Director - PO Medical

Clinical Laboratory Director - PO Medical page is loaded## Clinical Laboratory Director - PO Medic allocations:
US - WI - Madison time type:
Full time posted on:
Posted Todayjob requisition :
R26-12114
** Help us change lives
** 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 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…