Director- Histocompatibility

Overview:

Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.

Position Summary:

Under the direction of the Senior Director, Histocompatibility, Versiti DL, is accountable for helping to provide leadership and guide direction of the Histocompatibility Laboratories across Versiti, with a focus on clinical care, diagnostic innovation, education, and operational excellence. Contributes to the development and successful execution of business and strategic initiatives; contributes to managing the people and financial resources; contributes to ongoing and sustainable improvement in the areas of compliance, customer/employee satisfaction, and process improvement. Provides assistance to the Senior Director of Histocompatibility, as requested.

Responsibilities:

• Clinical and Scientific Leadership, Customer Service: Stays current with and contributes to best clinical practices in histocompatibility and transplantation, serving as an expert resource to our clients. Reviews clinical cases and provides clinical consultation as needed (including on-call). Performs annual chart reviews to re-evaluate interpretive comments in the context of current scientific publications and potential clinical implications. Identifies new technologies and/or tests that will add value to customers and patients, and participates in their development, validation, and operational implementation. Ensures own ongoing professional development through publications, presentations, and attendance at professional meetings, as well as leadership development training at Versiti. Actively engages and collaborates on clinical and scientific thought leadership locally (VBRI, MCW, FMLH and CW) and nationally (with clinical and industry partners). Contributes to clinical research activities of the lab, in collaboration with transplant programs and others external or internal partners. Maintains professional certifications (F(ACHI), ASHI, etc.)
• Laboratory Operations & Planning: Functions as a productive member of the laboratory leadership and director teams. Provides oversight to ensure compliance/service excellence/innovation/cost effectiveness in histocompatibility laboratories. Identifies and evaluates the latest technology and methodologies, and the development of innovative ideas for incorporation into operations. Ensure that new tests can be sustained from a training/competency/operational perspective. Demonstrates partnership and collaboration with operational management through participation and discussion, and alignment with organizational/team goals and decisions. Partners effectively with the Product Development (PD) program and provides leadership to PD within the lab. Serves as a technical resource to the laboratories for problem solving and process improvement. Contributes to operational plans which support the organizational strategic direction. Ensures that current standards and emerging concepts are incorporated into strategic and annual planning.
• Product Development and New Test Implementation: Oversees test development, performance and test interpretation. Identifies, evaluates, and implements opportunities for new or improved laboratory tests. Ensures that validation, SOPs and training have been completed before implementing a test in the laboratory. Ensures that performance is monitored and appropriate action taken. Under guidance of Senior Director, monitors performance of newly introduced tests and methods. Initiates action when inconsistencies or problems are identified.
• Regulatory Responsibility & Quality Assurance: Responsible for performing laboratory director and technical supervisor responsibilities per Clinical Laboratory Improvement Act (CLIA) ’88 regulations and as delegated per the Senior Director. Responsible for helping to ensure laboratories meet all applicable standards (ASHI, CAP, NY, etc.). Promotes and maintains compliance of laboratory operations with all applicable standards and regulations; ensures that regulatory changes are incorporated into laboratory standards and policy. Participates in developing and executing quality systems for laboratory operations and ensures that QC (quality control) and safety procedures are managed effectively. Oversees test performance and QA program review, and follow-up actions taken. Ensures approved proficiency program and laboratory staff competency programs are maintained; assures successful participation in proficiency testing.
• Leadership & Human Resource Management: Monitors and documents performance, sets goals in accordance with organizational priorities, and assists in coaching laboratory staff to improve performance. Accountable for competency testing program for histocompatibility laboratory positions. Provide leadership and direction for any positions reporting to this role. Participates as an effective member of the Diagnostic Laboratories management team and the Versiti management team. Communicates effectively with staff, management, and customers. Manages change constructively. Supports and promotes a culture of open, productive communication and responsibility in the laboratories. Promotes effective human resource management for any direct reports to include coaching/feedback, recognition, performance evaluation, hiring, discipline, and termination in collaboration with Human Resource Services and in compliance with administrative policy. Responsible for staff development in science, technology and leadership, to include goal setting, ongoing learning, and development of personal and departmental performance standards to meet service line initiatives.
• Continuous Improvement and Financial Management: Champions continuous improvement to create customer value more efficiently and effectively. Looks for creative ways to achieve laboratory growth targets and business objectives. Participates in the development and tracking of revenue plans. Meets or exceeds financial goals. Participates in the financial analysis of new opportunities. Evaluates, qualifies and recommends suppliers for equipment, software, and/or reagent purchasing.
• Performs other duties as required or assigned which are reasonably within the scope of the duties in this job classification.
• Understands and performs in accordance with all applicable regulatory and compliance requirements.
• Complies with all standard operating policies and procedures.

Qualifications:

Education:

• PhD plus Fellow of the American College of Histocompatibility & Immunogenetics F(ACHI) certification or M.D. with a strong knowledge of histocompatibility and immunology as evidenced by publications and post-doctoral experience. Must meet all new and revised CLIA regulations for HLA lab director degree requirements, training and experience as documented and signed in the CLIA Final Rule on 12/28/2023.

Experience:

• 10+ years experience in clinical histocompatibility and basic immunology preferred.
• 1-3 years experience in laboratory direction or management required.
• Experience with regulatory compliance and quality assurance required.
• Experience with assay validation and new test design preferred.
• Experience in developing and managing talent and budgets preferred.
• Experience with laboratory information systems required.

Knowledge, Skills and Abilities:

• Demonstrated expertise in the field of histocompatibility and immunology required.
• Excellent interpersonal, verbal and written communication skills required.
• Strong organizational ability to successfully manage a broad range of scientific, clinical and operational functions required.
• Strong leadership skills; demonstrated ability to manage and work in partnership with diverse teams, to influence cross-functional teams and lead change required.
• Demonstrated ability to provide clinical consultation to transplant physicians regarding HLA and donor selection, as well as other laboratory results relevant to pre-transplant evaluation and post-transplant monitoring required.
• Laboratory experience with solid phase, flow cytometric, and molecular methods as well as a demonstrated ability to develop new tests and apply new technologies required.
• Strong analytical ability to evaluate and ensure accuracy of data related to quality control and process improvement required.
• Demonstrated knowledge of CLIA regulations, ASHI regulations, and laboratory quality systems required.

Licenses and Certifications:

• HLA Laboratory Director Certification by the American Society for Histocompatibility and Immunogenetics (ASHI) in all solid organ and hematopoietic stem cell transplant categories; additional certification in disease association and transfusion support preferred upon hire required.

Tools and Technology:

• Personal Computer (desktop, laptop, tablet) required.
• General office equipment (computer, printer, fax, copy machine) required.
• Microsoft Suite (Word, Excel, PowerPoint) required.