Clinical Immunogenetics Laboratory Associate Director

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

With the Laboratory Director, is responsible for the scientific and technical oversight of the Clinical Immunogenetics Laboratory (CIL), which is specialized in histocompatibility assessment of patient and donor candidates before hematopoietic cell transplantation (HCT), post-HCT monitoring, as well as non-transplant related testing.

The Associate Director will provide expertise, review and approve the design, development and implementation of projects and processes within the CIL as delegated by the CIL Laboratory Director. This will include certain limited procedures and practices, along with supporting standard operating procedures (SOPs) validations and qualifications.

In collaboration with CIL Laboratory Director and the management team, the Associate Director will provide support for program planning, quality assurance, performance improvement, staff development, and identification of capital needs.

Responsibilities

• Regularly and directly participate in CIL clinical service/patient care activities. Respond to and address clinical care concerns regarding safety standards and practice issues that impact patient care. Oversee supervisory and technical steps in the performance of clinical duties; resolve technical problems.
• Review crossmatch, antibody, HLA typing, engraftment test results, PT results and world book search results and sign out clinical reports as needed.
• Ensure that testing systems and methodologies developed and performed for all Histocompatibility and Immunogenetic testing methods meet applicable quality requirements under ASHI standards and CLIA/CAP guidelines.
• Work in collaboration with the Laboratory Director, QA Senior Manager and lab management team to provide cross-departmental oversight and guidance for quality and safety.
• Under CIL Laboratory Director's guidance, provide technical and scientific oversight of CIL including development and implementation of new assays, procedures and practices, validations, qualifications, investigations, and planned and unplanned variances. Serve as an approver to controlled documents in CIL, as delegated by the CIL Laboratory Director.
• Ensure standard operating procedures (SOPs) are written and consistent with the methods performed in the laboratory and are adequate to determine the reliability, accuracy, precision, and other relevant characteristics of test methods. Ensure the establishment and maintenance of acceptable levels of analytical performance per SOP for each testing system and method. Ensure all necessary remedial actions taken are documented whenever significant deviations occur from the laboratory's established performance standards.
• Provide consultation to physicians and investigators in selecting safe donors for highly sensitized patients and monitoring post-HCT engraftment as needed.
• Stay up to date with the research and technology and continue to push scientific boundaries in the field of precision medicine.
• Provide opportunities for ongoing education and training for laboratory staff to maintain and enhance expertise in histocompatibility testing. Provide education to clinicians, fellows, residents, and other groups, as appropriate.
• Maintain current knowledge of regulations, requirements, and standards. Participate in the review of tracking and trending analysis and provide recommendations to ensure regulatory and accreditation compliance.

Qualifications

Required:

• Hold an earned doctoral degree in a chemical, biological, medical technology or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS or be a Doctor of Medicine, osteopathy or podiatric medicine licensed to practice medicine, osteopathy or podiatry in the state, or other jurisdiction in which the laboratory is located. Must meet the CLIA & ASHI education requirements for laboratory directorship.
• 4 years' experience in high complexity histocompatibility testing which includes at least 2 years of experience directing or supervising high complexity histocompatibility testing and 2 years of clinical training or experience in either the specialty of histocompatibility or general immunology.
• Must have HLA laboratory director certification from American College of Histocompatibility and Immunogenetics or be able to obtain HLA laboratory director certification within 1 to 2 years.
• Substantial theoretical knowledge and practical expertise in immunology, transplant immunology, serology, genetics, engraftment monitoring, new test/technology development/validation and technical troubleshooting.
• Strong leadership qualities; excellent communication and organizational skills.
• Attention to detail; excellent skills in critical thinking, problem solving and ability to make independent decisions.
• Demonstrated effectiveness in accomplishing objectives in a complex organization.
• Excellent interpersonal, verbal, and written communication skills.
• Demonstrated ability to lead and manage change.
• Must be able to work collaboratively with the CIL team, administrators and clinicians across Fred Hutch.

Preferred:

• Experience in both solid organ and hematopoietic cell transplant programs.
• Experience using HLA specific LIMS.
• Experience in executing big data analysis.