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CLIA Laboratory Director

Company:Sapient
Location:San Diego
Position:CLIA Laboratory Director

Description:

https://www.linkedin.com/talent/hire/489268708/job-post

CLIA Laboratory Director

About the Company:
Sapient is a fast-growing biotech startup that aims to accelerate drug development and transform personalized medicine. Combining state-of-the-art mass spectrometry technology with advanced computational services and multifaceted human health data, we enable biomarker discovery at unprecedented speed and scale. We are a team of passionate scientists, clinicians, and engineers with expertise in various disciplines. We work together in a highly collaborative environment, committed to making innovations with scientific rigor. We emphasize growth within the company and offer a flexible work environment with the opportunity work alongside top-tier thinkers and experts.

Role:
The CLIA Laboratory Director will lead and manage the direction of our high complexity CLIA lab, and shall be responsible for the proper performance of all Clinical Laboratory procedures and reporting of test results. They will oversee day-to-day operations of the CLIA lab, contribute to the building of a state-of-the-art mass spectrometry lab, oversee the development through approval of Lab Developed Tests (LDTs), and may supervise and manage staff from time to time, all while being a key part of the success of the Company – including by leading CLIA accreditation processes.

Essential Responsibilities:
• Lead and manage the accreditation process via College of American Pathologists
• Work hand in hand with executive staff to ensure the quality and growth of the CLIA lab
• Develop strategic roadmap to align key stakeholders
• Collaborate with scientists and clinicians to investigate scientific and medical problems with rigorous analyses and critical thinking
• Oversee method development process for mass spectrometry-based Lab Developed Tests (LDTs)
• Apply a comprehensive understanding of scientific principles to projects
• Both independently and collaboratively perform research with an emphasis on data quality and integrity in a time-efficient manner
• Shall be accessible to testing personnel when laboratory testing is performed to provide on-site, telephone, or electronic consultation to resolve technical problems in accordance with established policies and procedures
• Is responsible for monitoring the laboratory test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained
• Is responsible for the clinical laboratory specimen processing, test performance, and for reporting test results
• Shall follow the laboratory policies and procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results
• Shall maintain records that demonstrate that the laboratory proficiency testing samples are tested in the same manner as patient specimens
• Shall adhere to the Laboratory quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed
• Shall follow the clinical laboratory’s established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance
• Be capable of identifying and correcting problems that may adversely affect the laboratory’s test performance or reporting of test results
• Shall document all corrective actions taken when the laboratory’s test systems deviate from the laboratory's established performance specifications
• Assure that all remedial actions are taken whenever the laboratory department’s test systems deviate from the laboratory's established performance specifications
• Ensure that patient test results are not reported until all corrective actions have been taken and the laboratory’s test system is properly functioning
• Provide orientation to all laboratory testing personnel; annually evaluate and document the performance of all department’s testing personnel

Qualifications:
• Requires an MD or PhD in chemistry, biochemistry, biology, or related scientific field or in clinical laboratory science from an accredited institution and be certified by a board approved by HHS
• Experience deploying mass spectrometry for the detection and characterization of biomolecules, specifically proteins, oligonucleotides, and small molecules from biological samples
• Qualified to provide general supervision in accordance with CLIA regulations and California State Business and Professions Code
• Organized and driven, critical and creative thinker
• Excellent oral and written communication skills