Trinity Health Scientific Director - Warde Medical Laboratory in Ann Arbor, Michigan
The SDL-Lab Section Warde serves as the Scientific Director of the Clinical Virology and Molecular Biology laboratory section. This individual is responsible for the administrative, technical and scientific oversight of their assigned discipline including method evaluation. Provides leadership for the staff and for associated technical departments. Plans, organizes, and directs the activities of the department directly and/or with the assistance of and senior technologists. Serves as a subject matter expert for clients, Trinity-Health, and potential customers.
Warde is an esoteric testing laboratory. Our primary purpose is to perform expensive tests, difficult-to-perform tests, and/or tests requiring specialized instrumentation or expertise. Our clients pay a premium price for this type of testing through the national reference laboratories. Our goal is to pool co-tenant testing volumes and through economies of scale and economies of scope, reduce the cost of this testing.
Many of these tests have no In Vitro Diagnostic device (IVD) equivalent because they are considered low-volume for an individual hospital account. The major challenge is to design, validate, and manage laboratory developed tests (LDT). The Scientific Director must keep abreast of the scientific literature, the LDT regulatory environment, and keep the LDTs relevant when virus genomes change. The corollary challenge is to maximize testing efficiencies so that we can provide high-quality results at a lower unit cost.
The Virology and Molecular Biology laboratory is located within Warde Medical Laboratory, a 35,000 sq. ft. esoteric testing facility located at 300 W. Textile Road in Ann Arbor. The department is about 5,000 sq ft. of contiguous space. The area is configured for real-time PCR testing with a single 4,300 sq. ft. open-architecture workspace. The remaining space houses an autoclave room, clean room, FA microscopy room, and two offices, all of which open into the laboratory.
SHORT AND LONG TERM GOALS
Six to twenty four month expectations and goals for this position: 1. Bring in new tests to grow the business and replace repatriated tests. 2. Make changes necessary to accommodate New York State licensure of the lab. 3. Cost containment in accordance with our charter. 4. Work with Finance to update the cost profiles for existing procedures. 5. Get ready for CAP inspection. 6. Prepare Warde Report informational papers to support our clients and current operations 7. Research, identify and develop innovative methodologies to advance existing tests to increase efficiency and quality.
The SD-Lab Section Warde serves as the Scientific Director of their assigned laboratory section. This individual is responsible for the administrative, technical and scientific oversight of their assigned discipline including method evaluation. Provides leadership for the staff and for associated technical departments. Plans, organizes, and directs the activities of the department directly or with the assistance of supervisors and senior technologists.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
The Scientific Director lives the corporate values, supports the goals of the organization, and provides leadership in their area of responsibility. Is accountable for the quality and timeliness of laboratory testing in their section. Develops and maintains mechanisms to assure that all tests are performed properly and that all test results are valid and accurate prior to release; conducts regular audits of laboratory procedures, worksheets and logs. Ensures that the laboratory section and the staff comply with corporate policies and all accreditation, licensing and regulatory standards. Responsible for maintaining appropriate staffing levels; recruits, hires and terminates department staff as appropriate; responsible for oversight of section personnel. Completes employee performance evaluations in a timely manner. Ensures that all testing personnel are adequately trained and technically competent to perform their assigned duties. Oversees retraining as necessary. Responsible for maintaining a productive working environment, manages employee development and recognition. Participates in employee engagement surveys. Plans and reviews strategies for improving employee engagement. In cooperation with the Director of Operations/Administrative Director, develops operational objectives, plans and budgets for the laboratory section. Monitors and revises these plans and budgets to coincide with changing business objectives. Prepares and justifies capital budgets. Researches, develops and implements clinically appropriate laboratory testing policies and procedures that are consistent with current good laboratory practices, CLIA, and CAP requirements. Maintains and updates test and operational procedures as necessary to reflect current laboratory practices and regulatory imperatives. Responsible for evaluating and selecting new procedures, methods, instruments, and equipment. Responsible for adequately training the laboratory staff regarding new procedures, methods, and equipment. Responsible for assuring that assigned employees follow established procedures. Responsible either directly or through designated individuals for equipment maintenance, calibration, proper usage, and obtaining appropriate service when needed. Responsible for stock supplies and selecting replacements at favorable prices consistent with quality, quantity and efficiency. Responsible for obtaining and maintaining appropriate supply levels in support of published turnaround time and service level requirements. Investigates and resolves technical and administrative problems. Communicates effectively with management, vendors, clients, and regulatory agencies. Acts as a liaison between the laboratory and its referring clients to mediate problems, gather information, and sell services. Provides assistance and acts as a resource for internal and external customers. Participates in client visits and presentations as required. Participates on laboratory committees as required. Assumes responsibility for the timely completion of special projects as directed by the Administrative Director in coordination with the Medical Director. Provides test result interpretations for internal and external customers. Serves as a technical expert in their area of responsibility. Personally maintains a satisfactory level of continuing education and professional accreditation for the professional area of expertise. Develops and maintains contacts with educational institutions, professional organizations, government agencies, etc. to keep abreast of changes and developments in the appropriate disciplines. Assumes the technical supervisor and technical consultant responsibilities as described under CLIA. Prepares statistical reports regarding laboratory operation.
OTHER FUNCTIONS AND RESPONSIBILITIES
Prepares lectures and other continuing education activities for internal and external customers. Promotes and represents the laboratory favorably and in line with the stated mission and goals of the organization.
REQUIRED EDUCATION, EXPERIENCE AND CERTIFICATION/LICENSURE
Doctoral degree from an accredited college/university in the field appropriate to the section or a related laboratory science. Three to five years of progressively more responsible experience in a clinical laboratory. Meets CLIA requirements as technical supervisor and technical consultant in their area of expertise.
REQUIRED SKILLS AND ABILITIES
- Outstanding interpersonal communication skills
- Team building/ facilitation skills
- Conflict Resolution
- Presentation skills
Business Process Skills
- Excellent problem solving skills
- Able to manage change
- Effective organizational, analytical, and project management skills
- Able to develop and manage a budget
- Competent in Microsoft Office applications
- Familiar with Laboratory Information Systems from the user perspective
- In depth knowledge of the science and technology of assigned disciplines
- Familiarity with Quality Management and Quality Improvement Principles.
- Familiarity with laboratory safety and infection control policies and procedures.
- Familiarity with CSLI, OSHA and other regulatory standards pertaining to their laboratory section.
- Familiarity with CPT coding, CMS compliance regulations and OIG standards as pertains to laboratory practice.
- In depth knowledge of method validation procedures and practices.
- In depth knowledge of CLIA and CAP regulations and the measures to assure compliance with these regulations.
Job Number: 00119129
Location: Ann Arbor, MI
Organization Name: Saint Joseph Mercy Health System
Facility: SJSEMI - SJMHS Warde Medical Laboratory
Employment Type: Full time
Shift: Day Shift