JOB DESCRIPTION:The Opportunity
This position works out of our Madison, WI location in the Cancer Diagnostics, legacy Exact Sciences, division. We're advancing the fight against cancer by delivering innovative diagnostic solutions that help detect, characterize, and monitor disease with greater precision. Our portfolio of molecular and genomic technologies empowers clinicians with actionable insights to support personalized treatment decisions and improve patient outcomes across the cancer care continuum.
As the Clinical Laboratory Director, you be an engaged, key partner working collaboratively across the organization to inform the development, validation, ongoing monitoring, and improvement of our clinical tests. This individual will hold the CLIA license, and will integrate technical expertise, medical guidelines and clinical laboratory standards to deliver clear guidance, drive resolution, and ensure best-in-class test offerings. This dynamic role interacts with Research and Development, Product Development, Medical Affairs, Operations and Quality.
Essential Duties
All responsibilities defined for a CLIA license holder (see CLIA, CAP), with emphasis on representing current technical and medical standards to:
- Ensure the technical and medical performance of our tests meet current medical and technical standards (professional societies, regulatory checklists, additional guidelines and standards)
- Collaborate with commercial, research and development and operations to ensure test performance, validations
- Ensure strong engagement with quality monitoring, quality improvement framework:
- Monitor performance of tests, identify trends, evaluate risk, and drive resolution and improvement of test performance
- Support escalations, risk assessments and timely resolution of testing concerns
- Represent medical and technical standards for best practice
- Support clinical consultation
- Stay abreast of and integrate emerging guidelines, medical and regulatory standards and apply to current and future test offerings
- Coordinate across multiple groups to drive informed, risk-based solutions
- Ability to effectively delegate in a matrixed environment
- Additional requirements:
- Excellent critical thinking, risk assessment and mitigation skills
- Strong understanding of technical components of testing, including bioinformatics and Information Technology
- Highly collaborative, problem-solving approach
- Ability to manage confidential information.
- 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 companys Quality Management System policies and procedures.
- Maintain regular and reliable attendance.
- Standing or sitting for long periods of time may be necessary.
- Use of computer and some time may be spent concentrating, reading, or analyzing data, or applying scientific rules.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for up to approximately 95% of a typical working day.
- Ability and means to travel between Exact Sciences locations.
- Ability to travel approximately 10% of working time away from work location, may include overnight/weekend travel
Minimum Qualifications
- Qualified to hold a CLIA license for a high complexity laboratory:
- American Board of Pathology or American Osteopathic Board of Pathology board certification in: Anatomic Pathology or Anatomic and Clinical Pathology Molecular Pathology, or ABMGG Board certification in Laboratory Genetics and Genomics or Molecular Genetics
- NYS DoH Certificate of Qualification (or eligible) in relevant discipline(s)
- Demonstrated ability to perform the essential duties of the position with or without accommodation.
- Authorization to work in the United States without sponsorship.
The base pay for this position is
$149,300.00 6 $298,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Clinical Affairs / Statistics
DIVISION:ONCO Cancer Diagnostics
LOCATION:United States > Madison : 5505 Endeavor Ln
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)
