The Director, Clinical Laboratory Operations provides strategic leadership and consultative support to the leaders of the Clinical Laboratories (Baltimore, MD and Cambridge, MA) to develop and manage strategy including planning, budgeting, and forecasting. The position works closely with other functions within the Laboratory Operations teams to ensure consistency and best practices in the applicable shared processes across all lab sites. This position will also be responsible for representing Laboratory Operations in the evaluation and diligence activities of Business Development opportunities. The Senior Director, Laboratory Operations is responsible for working alongside leaders of all clinical laboratories, other enabling functions, and business functional areas (i.e., Quality, IT, Finance, HR, Facility, and more) to maintain Quality Systems in compliance with CLIA, CAP, and other applicable state regulations.
Essential Duties and Responsibilities
include but are not limited to the following:
In partnership with the VP, Laboratory Operations, participate in strategic planning for laboratory services and future product pipelines.
Serve as a resource to establish necessary laboratory performance metrics to achieve and sustain outstanding quality and customer service.
Represent the Laboratory function in Business Development diligence activities and prepare reports for senior management on findings.
Ensure adherence to CLIA/regulatory requirements and lab quality standard elements.
Inform, integrate, and optimize integration activities, as well as long-term operational strategies.
Execute due diligence and assist with integration plans, ensuring deadlines are met, and risks are mitigated.
Identify and creatively solve complex, cross-functional operational issues that get in the way of successful outcomes.
Coordinate, lead, mentor, and support process improvement projects within functional roles to drive cost savings, efficiencies and productivity. Quantify savings through partnering with financial analysts.
Coordinate and manage cross-functional priorities internally.
Consult, as necessary, on development of standard operating procedures (SOP) required for the performance of diagnostic testing. Draft, edit, review, and approve SOPs as required.
Ensure that all licensure for diagnostic testing is in place and testing is in compliance with state and local regulations.
Serve as a resource to ensure that the test methodologies selected have the capability of providing the quality of results required and verifies, as appropriate, that procedures are accurate and precise.
Serve as a resource to sales and marketing to ensure all product descriptions (electronic and paper) are correct and compliant with CLIA and regulatory requirements.
Serve as a resource in creation, validation, documentation, and approval of specimen pre-analytical, analytical, and post-analytical results.
Prepare for, participate in, and perform inspections, as necessary, to maintain licensure and ensure quality service delivery.
Consult with stakeholders across the industry and inside Exact Sciences cross-functionally to seek solutions for strategic and operational challenges.
Prepare and deliver presentations for both internal and external audiences.
Provide clinical laboratory regulatory guidance for the development of all new products.
Promote an open, collaborative environment built on trust to foster positive teamwork.
Direct mid-level management for organized and prioritized work, mentor for leaders to write/conduct performance reviews, train/develop, and manage work performance.
Communicategoals clearly to employees to ensure understanding and success in achieving them.
Motivateandinspireemployees to do their best work through coaching.
Maintainmorale and support employee engagement initiatives.
Ability to manage multiple projects with successful follow-through and timely delivery.
Strong communication, collaboration, business, clinical judgment, and organizational development skills.
Ability to manage and prioritize multiple projects and initiatives with excellent project planning and execution skills.
Strong interpersonal and teamwork skills; including the ability to easily convey concepts and priorities to peers, customers, and cross-functional teams.
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.
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 and means to travel between locations (eg, Baltimore, MD; Cambridge, MA; Madison, WI).
Ability to travel 40% of working time away from work location, may include overnight/weekend travel.
Bachelor's degree in Biology, Chemistry, Genetics, Microbiology, or related field; or Medical Technologist Degree and certification in MT (ASCP), MC/MB (ASCP), or CLS (ASCP).
12+ years of experience effectively working in a clinical laboratory environment in the healthcare industry.
10+ years of managerial or supervisory experience.
5+ years of experience working under Clinical Laboratory Improvement Amendments (CLIA) regulations and other state regulations (such as New York and California).
1+ years of director level managerial experience in a high-volume, high-complexity, CAP and CLIA regulated clinical laboratory environment.
Proficient in Microsoft Office to include Excel macros and pivot tables and Word mail merge.
Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
Authorization to work in the United States without sponsorship.
MBA or advanced degree.
Lean Six Sigma certification and demonstrated application of lean philosophy and tools.
Qualifies as General Laboratory Supervisor under CLIA.
Prior experience desired in management of laboratory business, including areas as finance, operations, client services, specimen processing, total quality management, and technical service.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.