Senior Clinical Manager - Immunogenetics and Transplant Diagnostics (ITD)

Mass General Brigham•Boston, MA

14h•Onsite

About The Position

The Senior Clinical Manager will partner with Immunogenetics and Transplant Diagnostics (ITD) and Mass General Brigham Pathology leadership to build a fully integrated immunogenetics laboratory. ITD operates across two laboratory sites and provides histocompatibility testing for solid organ and hematopoietic progenitor cell transplantation, as well as specialized non-transplant diagnostics. The service performs approximately 60,000 HLA and histocompatibility-related tests annually and supports Mass General Brigham transplant programs, the OPTN Region 1 Organ Procurement Organization, and additional transplant hospitals across New England. The position is responsible for daily laboratory operations, including staffing, workflow, quality, safety, and regulatory compliance, and provides management and strategic direction across multiple sites. The manager ensures compliance with applicable federal, state, and accreditation requirements and collaborates with local and system leaders. This is an on-site role with rotation between sites based on operational and situational needs. The position does not require patient care.

Requirements

Meet CLIA qualifications for a general supervisor of a high-complexity laboratory performing histocompatibility testing (CFR § 493.1461), ASHI standard E.5.1, and applicable OPTN and Massachusetts Department of Health regulations.
Five to seven years of laboratory experience.
Three to five years of demonstrated leadership experience in a hospital-based CLIA laboratory.
ASCP Certified Medical Technologist credential (MLT, MT, MLA, or Histologists) is required.
Bachelor's degree in Laboratory Sciences is required; experience cannot substitute for the degree.
Detailed knowledge of regulatory requirements, including CAP, Joint Commission, and CLIA.
Expert knowledge of laboratory health and safety protocols.
Strong knowledge of personnel and employment practices.
Ability to manage staffing levels and workloads, and to interview and train new employees.
Effective written and verbal communication skills, including sufficient English comprehension to communicate with patients, laboratory personnel, and others.
Technical expertise across histocompatibility testing, including NGS-based HLA typing, HLA antibody identification and characterization, DSA testing, physical flow and CDC crossmatching, virtual crossmatching, chimerism testing, and ABO testing.

Nice To Haves

Progressive operational leadership experience managing large, complex histocompatibility laboratories supporting multi-hospital transplant programs and organ procurement organizations.
Knowledge of OPTN Region 1 operations.
Success overseeing high-volume, 24/7 laboratory operations, including turnaround time, competency assessment, key performance indicators, capital and equipment planning, and financial stewardship.
Experience partnering with transplant physicians, surgeons, clinical care teams, OPO leaders, IT, billing and compliance, quality, and administrative leaders.
Exceptional communication, execution, collaboration, and relationship-building skills across technical, clinical, and executive stakeholders.
Demonstrated success leading process improvement, technology implementation, assay implementation and validation, and operational change in a complex clinical laboratory.
Experience developing sustainable staffing models and leading mentoring, career development, performance management, scheduling, productivity, inventory management, and resource allocation.
Experience developing and maintaining comprehensive quality management systems.
Expertise with laboratory information systems and integration of laboratory testing platforms, instrumentation, interfaces, and IT solutions.
Master's degree in a related field.

Responsibilities

Develop and maintain quality assurance systems, review performance information, identify improvement opportunities, and address root causes of performance deviations.
Review event management reports, investigate complaints and problems, and analyze data for trends or patterns.
Ensure validation protocols and summaries are created for new or changed processes.
Assign, monitor, and supervise work to ensure compliance with laboratory SOPs, regulatory and accreditation requirements, health and safety requirements, and patient confidentiality standards.
Prepare the laboratory for regulatory reviews and inspections, including those by TJC, CAP, and FACT.
Coordinate clinical trials with principal investigators, study coordinators, quality assurance, and compliance teams.
Manage computer systems used to access clinical laboratory results, produce worksheets, and collect or analyze data.
Conduct interviews and recommend candidates for hire in accordance with departmental policies.
Oversee staff orientation, training, competency assessment, and continuing education, including required safety, infection control, and compliance training.
Oversee laboratory staffing, workflow, quality management, turnaround time, regulatory compliance, performance indicators, capital and equipment planning, and budgeting.
Partner with Pathology and laboratory medical and clinical leadership to support multiple transplant programs and coordinate testing and reporting for urgent, time-sensitive clinical decisions.
Lead process improvement, technology implementation, assay implementation and validation, and operational change.
Lead workforce planning and management, including staffing models, mentoring, career development, performance management, scheduling, productivity, inventory management, and resource allocation.
Develop and maintain quality management systems, including proficiency testing, competency programs, corrective and preventive actions, document control, and continuous improvement.
Support laboratory information systems and integration of testing platforms, instrumentation, interfaces, and information technology solutions.