Clinical Laboratory Director - PreventionGenetics

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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 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 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.
• 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 act with an inclusion mindset and model these behaviors for the organization.
• Ability to work designated schedule.
• Ability to work nights and/or weekends, as needed.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to work on a computer and phone simultaneously.
• Ability to use a telephone through a headset.
• Ability to periodically work standing for approximately 90% of a working day.
• Ability to lift up to lift greater than 25 pounds occasionally on a typical working day.
• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to use various types of laboratory equipment; including microscopes, microtomes, blades, strainers, and pipettes for extended periods of time.
• May perform repetitious actions using lab tools.
• Ability to use near vision to view samples at close range.
• May be exposed to hazardous materials, tissue specimens, and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
• Ability and means to travel 30% between local Exact Sciences locations. Must be on site in Marshfield a minimum of 1-2 days per week
• Ability to travel 10% of working time away from work location, may include overnight/weekend travel.
• You will be required to successfully complete an assessment showing understanding of Exact Sciences Epic processes necessary to the job functions with a score of 80% or higher. Exact Sciences will make a reasonable accommodation available, if necessary, to assist an employee with a disability to satisfy this requirement.

Minimum Qualifications

• Ability to meet one of the qualifications below:
  • MD or DO with a current medical license & board certification in Anatomic and/or Clinical Pathology or possess equivalent qualifications as those required for certification OR
  • MD, DO or DPM with a current medical license and laboratory training/experience consisting of the following:
    • 1 yr laboratory training during medical residency OR
    • 2 years' experience supervising high complexity testing OR
  • Doctoral degree in chemical, physical, biological or clinical laboratory sciences with certification by a board approved by HHS
• Ability to obtain and hold NY CoQ in molecular genetics and maintain throughout employment in position
• Experience leading teams, projects, and/or committees with a demonstrated ability to lead through influence.
• Strong understanding of molecular testing and techniques
• Excellent analytical, critical thinking and risk management skills
• Proficient in Microsoft Office programs, such as: Word, Excel, PowerPoint, Outlook, Access, OneNote, Publisher, and SharePoint.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.
  

Preferred Qualifications

• ABMGG certification

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 age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Any applicant or employee may request to view applicable portions of the company's affirmative action program.

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