Clinical Laboratory Director - Prevention Genetics

Exact Sciences • Marshfield, WI

287d

About The Position

At Exact Sciences, we're helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others. 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 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, 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.

Requirements

• 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.
• MD, DO or DPM with a current medical license and laboratory training/experience consisting of 1 yr laboratory training during medical residency or 2 years' experience supervising high complexity testing.
• 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, SharePoint.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Nice To Haves

• ABMGG certification

Responsibilities

• 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.
• Liase with 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.
• Support and ensure incident investigation, corrective and preventive action.
• Collaborate with cross-functional partners on efforts during new product commercial launches.
• 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.

What This Job Offers

• Job Type: Full-time
• Industry: Ambulatory Health Care Services
• Education Level: Ph.D. or professional degree