Director of Clinical Laboratory Services

Renalytix is an In-Vitro Diagnostics laboratory services provider of precision medicine solutions in Chronic Kidney Disease. Our lead product, kidneyintelX.dkd has received FDA approval as a first in class prognostic test to predict risk of kidney failure in patients with Type 2 Diabetes and CKD.

As we scale our commercial and clinical programs, we are seeking a highly experienced and dedicated Clinical Laboratory Professional (Director Level) to lead our clinical laboratory operations and analytical development activities. This role requires a dynamic individual with a strong background in clinical laboratory science, exceptional leadership skills, and a thorough understanding of quality management systems and regulatory requirements. The successful candidate will oversee the daily operations, ensure compliance with state and federal regulations (including FDA, NYSDOH, CAP, CLIA) and drive the laboratory's strategic goals and objectives.

Key Responsibilities:

Leadership and Management:

Provide strategic and scientific leadership in the delivery of effective, quality assured and patient-centered laboratory services

• Ensure the promotion of awareness of internal and external customer needs and requirements in defining, implementing, monitoring and continuous improvement of laboratory systems and processes.
• Management of supervisory processes for laboratory and bench staff, including hiring, training, scheduling, and performance evaluations
• Foster a collaborative and productive work environment in the develop and implementation of laboratory policies and procedures to ensure efficient and effective operations
• Work proactively with internal and external clinical, scientific, regulatory and technology stakeholders in the definition and execution of Research & Development programs
• Liaise with finance and operations departments to ensure effective budgeting and efficient utilization of resources.

Operational and Quality Oversight:

• Oversee the day-to-day operations of the clinical laboratory, including specimen processing, testing, quality control, and result reporting as well as laboratory services for academic research collaborations, pharmaceutical company services and product pipeline development
• Ensure the laboratory meets all quality standards and maintains accurate and timely data & documentation records
• Ensure robust processes for troubleshooting and resolving technical and data issues related to laboratory equipment, material, personnel and procedures
• Ensure compliance with all applicable state and federal regulations, including the Food and Drug Administration (FDA), New York State Department of Health (NYSDOH), College of American Pathologists (CAP), and Clinical Laboratory Improvement Amendments (CLIA).
• Monitor and continuously improve Quality Management Systems as applicable with particular focus on quality control programs, equipment controls and operator proficiency
• Conduct regular internal audits and provide laboratory leadership in external audits and inspections to maintain accreditations and certifications

Candidate Profile:

• A Master’s degree in Clinical Laboratory Science, Medical Technology, or a related field with a minimum of 8-10 years of experience in a clinical laboratory setting, with at least 5 years in a supervisory or managerial role
• Must meet current New York State Clinical Laboratory Supervisor requirements
• Prior responsibility in the development, validation, and regulatory approval of immunoassays in accordance with FDA, CLSI or equivalent requirements
• Proficiency with laboratory information systems and related software
• Strong analytical skills with proficiency in statistical analysis software (e.g., Analyse-it, SPSS, SAS, R).
• Advanced problem solving and decision-making skills with a relentless focus on continuous improvement and customer satisfaction. Experience of Lean/ Six Sigma methodologies is desirable.