Leadership. Provides oversight and leadership while ensuring high-quality patient testing for clinical trials. Provides effective and efficient administrative direction of the laboratory, including budget planning and controls in conjunction with the individual(s) responsible for financial management of the laboratory. Direct and supervise technical performance of staff. Ensure staff competency and resources. Support continuing education of staff.
Quality. Ensures laboratory compliance with all applicable regulatory agencies and guidelines, including but not limited to: NYS CLEP, College of American Pathologists (CAP),CLIA, FDA, ICH and specific state requirements of CA, FL, MD, ME, NJ, NY, OK, PA, RI, and VT. Guarantees laboratory compliance with Good Clinical Practice and Good Laboratory Practice. Ensures the implementation of a safe laboratory environment in compliance with good practice and applicable regulations. Oversee all aspects of the laboratory's quality management program. Ensures that policies and procedures are established for monitoring staff to assess competency, and whenever necessary, provide remedial training or continuing education to improve skills.
Partnership. Collaborates with business and operational leaders to ensure the proper test offerings and to develop/introduce new technologies and develop new and novel assays. Partners with Scientific Affairs to ensure that the test menu is current. Partners with Laboratory Operations globally in the selection of all laboratory equipment, supplies, and services with respect to quality (or designee). Interacts and maintains good relationships with applicable regulatory agencies as well as the professional community.
Development & Validation. Works closely with and oversees the development of new testing methods for the laboratory and ensures that new testing methods/analytes are properly prioritized and works with finance and operations to assist in developing the ROI for new test offerings. Ensures that the performance specifications for new tests, instruments, and methods introduced to the laboratory have been properly validated or verified prior to being used for clinical trial testing. Ensures that proficiency testing, alternative assessment, and QC procedures are sufficient for the extent of testing performed in the laboratory.
Ph.D. in Biomedical Sciences, such as, Chemistry, Biology, Immunology, etc. required.
10 years' experience in clinical trials, research and/ or clinical laboratory required.
2 years of laboratory supervision preferred.
Experience in Good Clinical Practice (GCP).
Good Laboratory Practice (GLP) and/or Good Clinical Laboratory Practice (GCLP) preferred.
Experience with College of American Pathology (CAP), Medicines & Healthcare products Regulatory Agency (MHRA), and/or Food & Drug Administration (FDA) preferred.