JOB DESCRIPTION:Position OverviewThe Associate Laboratory Director is responsible for ensuring the medical and technical performance of tests delegated by the laboratory director, as well as serving as a subject matter expert (42 CFR 493.1451). These responsibilities include, but are not limited to, ensuring delegated 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 Associate 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 Associate 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 DutiesInclude, but are not limited to, the following:
- Support the clinical laboratory director to ensure effective functioning of all tests
- Effective communication regarding all delegated activities
- 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.
- Liase 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 training and competency programs are appropriate
- 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 training, documenting standard operating procedures (SOPs), reviewing marketing materials, etc.
- 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.
Minimum Skills and 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 high complexity testing OR
- Doctoral degree in chemical, physical, biological or clinical laboratory sciences with certification by a board approved by HHS OR
- Doctoral Degree in relevant science plus 1 year training OR
- 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
- Excellent communication skills
- Be onsite at least 4 days/week
- Apply excellent written and verbal communication skills to convey difficult information in a clear, kind, and respectful manner.
- 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.
- Ability to work in and contribute to a fast-paced, highly collaborative environment.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Authorization to work in the United States without sponsorship.
- ABMGG certification
- Ability to hold NY CoQ in molecular genetics
The base pay for this position is $113,300.00 - $226,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Research and Discovery
DIVISION:ONCO Cancer Diagnostics
LOCATION:United States > Madison : 1 Exact Lane
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 5 % of the Time
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
