Senior Clinical Laboratory Medical Director

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 Senior Clinical Laboratory Medical Director is responsible for the overall operation and administration of the Clinical Laboratory; including, but not limited to, the employment of personnel who perform test procedures, record, and report test results promptly, accurately, and proficiently and for assuring compliance with the applicable regulations.

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 all clinical laboratory duties are properly performed.
• Remain accessible to laboratory to provide on-site, telephone, or electronic consultation, as needed.
• 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 laboratory conditions are appropriate for testing performed and provide a safe environment in which employees are protected from hazards.
• Ensure that test methodologies have the capability of providing the quality of results required for patient care.
• Ensure verification procedures used 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 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 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.
• Ensure that consultation is available to clients on the quality of test results and their interpretation.
• Ensure that a general supervisor provides on-site supervision of high complexity test performance.
• Ensure personnel have the required education, laboratory experience, and are appropriately trained and competent to perform test methods as required for accurate and reliable results.
• Ensure that policies and procedures are established for monitoring individuals who conduct any phase of testing, to assure they are competent and maintain their competency, and to identify needs for remedial training and continuing education to improve skills.
• Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process.
• Develop in writing the responsibilities and duties of each consultant, supervisor, and each person engaged in all phases of testing; identify which examinations each individual is authorized to perform, whether supervision is required, and whether supervisory or laboratory director review is required before reporting test results.
• Report all concerns of test quality and/or safety to a supervisor or safety officer.
• 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.
• Ability to lift up to 10 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 typic