Laboratory Director – High Complexity CLIA Laboratory

Consulting Laboratory Director – High Complexity CLIA Laboratory
Company: MiRNDa
Potential locations: Texas (TX), Massachusetts (MA), California (CA), or Minnesota (MN)
Engagement: Independent contractor / consulting agreement
Expected start: Q1 2027 (January–March)
MiRNDa is a biotechnology startup developing RNA modification–based diagnostics to improve the early detection of hard-to-detect cancers, with an initial focus on pancreatic cancer.
We are seeking an experienced Laboratory Director to support the establishment and operation of a high complexity CLIA laboratory in the United States. We welcome candidates qualified to serve in one or more of the states listed above. Candidates who can also serve as Technical Supervisor and Clinical Consultant for the laboratory’s testing scope are particularly encouraged to apply.
The Laboratory Director will work closely with MiRNDa’s leadership and scientific team to establish reliable clinical laboratory operations and support the implementation of our diagnostic technology.
Responsibilities include:
Serve as the designated Laboratory Director, with overall responsibility for laboratory operations, testing quality, and compliance with CLIA, applicable state regulations, and relevant accreditation standards.
Guide laboratory setup and readiness for clinical testing, including assay validation, quality systems, and inspection preparation.
Review and approve laboratory procedures, validation protocols, and performance reports.
Oversee quality control, quality assessment, proficiency testing where applicable, and corrective actions.
Ensure laboratory personnel meet qualification, training, and competency requirements.
Provide ongoing consultation and complete required on-site visits.
Where qualified and mutually agreed, also serve as Technical Supervisor and/or Clinical Consultant.
Required qualifications:
Meet the CLIA qualifications for a Laboratory Director of high complexity testing under 42 CFR §493.1443.
Hold, or obtain before assuming the role, all licenses and credentials required for the relevant state and laboratory testing scope.
Demonstrated experience directing or supervising high complexity clinical laboratory testing.
Strong knowledge of laboratory quality systems, assay validation, and regulatory compliance.
Ability to meet the role’s oversight, consultation, and on-site requirements beginning in Q1 2027.
Strong communication skills and the ability to collaborate with a multidisciplinary team.
Preferred qualifications:
Eligibility and willingness to serve concurrently as Technical Supervisor and Clinical Consultant, meeting the separate requirements for each role.
Experience establishing a CLIA laboratory or introducing laboratory-developed tests (LDTs) into clinical practice.
Experience with LC-MS/MS, clinical chemistry, RNA-based assays, or oncology diagnostics.
Experience with CAP accreditation and laboratory inspections.
Experience working with early-stage biotechnology companies.
The scope of services, time commitment, and consulting fees will be agreed based on the laboratory’s needs and the candidate’s qualifications.
To apply, please send your CV and a brief summary of your relevant experience to info@mirndainc.com. Please include the state(s) in which you are qualified to serve, your relevant licenses and board certifications, current laboratory director appointments, eligibility to serve as Technical Supervisor and Clinical Consultant, and availability to start in Q1 2027.

Work arrangement
Yes