Clinical Laboratory Director

Abbott; United States; On-site; USD 140,000 - 210,000; Full time

Job summary

Abbott in Madison, WI is seeking a Clinical Laboratory Director to lead the development, validation, and ongoing monitoring of our clinical tests within the Cancer Diagnostics division. This role requires CLIA high-complexity license oversight and strong collaboration across Research & Development, Medical Affairs, Operations, and Quality to ensure test performance aligns with medical standards.

The successful candidate will integrate clinical guidelines, laboratory standards and advanced

Qualifications

• CLIA license eligibility for a high complexity laboratory.
• Board certifications in Anatomic Pathology or Molecular Pathology as applicable.
• Ability to integrate medical guidelines with laboratory standards.

Responsibilities

• Oversee CLIA license compliance and test performance.
• Collaborate with R&D, Medical Affairs, Operations and Quality.
• Assess risks, monitor test performance, drive improvements.
• Provide clinical consultation and guidance on test offerings.

Skills

Critical thinking

Risk assessment

Collaboration

Communication

Bioinformatics

Information Technology

Education

Board certification in Anatomic Pathology

Board certification in Molecular Pathology

CLIA high-complexity license eligibility

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Working at Abbott

At Abbott , you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year .
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

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 company's 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 c