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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.
Job Responsibility:
Responsible for the overall operation and administration of the Clinical Laboratory as well as serving as a pathology expert
Hold the CLIA license for the clinical laboratory
Support and/or delegate as appropriate all duties established under CLIA requirements
Review tissue sent in for commercial assays
Provide medical expertise in the assessment of patient materials
Support physicians regarding patient results and laboratory processes
Train the Clinical Pathology staff
Review Clinical Pathology analytics
Participate in the Quality Management System
Work closely with cross-functional team members in the improvement and development of new processes and technologies
Perform duties of clinical consultant, technical supervisor, general supervisor, and testing personnel, if qualified, as needed, or delegate these responsibilities to qualified personnel
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
Ensure that test methodologies have the capability of providing the quality of results required for patient care
Ensure validation and verification procedures are adequate
Ensure laboratory personnel are performing the test methods as required
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
Ensure the establishment and maintenance of acceptable levels of analytical performance
Ensure that patient test results are reported only when the test system is functioning properly
Ensure that test result reports include pertinent information required for interpretation
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
Review submitted pathology reports and materials
Provide global pathology product and service support
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
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
Requirements:
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
1+ years of laboratory training during medical residency
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
Nice to have:
Strong molecular experience and/or formal molecular training
Completion of a Subspecialty Fellowship
What we offer:
Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
A retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage