Position Summary:
The Laboratory Director provides scientific, technical, and regulatory leadership for all PCR (molecular) and toxicology testing performed within the laboratory. This role ensures the accuracy, reliability, and clinical validity of all testing, maintains full compliance with CLIA, CAP, DEA, and applicable state and federal requirements, and supports continuous improvement in quality, turnaround time, and operational performance.
The Lab Director must exhibit strong leadership, communication, organizational, interpersonal skills, and must demonstrate the ability to solve problems and analyze complex issues and make sound decisions in a timely manner. The Lab Director must be able to respond to and lead change, adapt quickly to evolving circumstances, and address difficult issues quickly.
The Laboratory Director works in close partnership with the Lab Technicians, Lab Specimen Collectors, Lab Accessioner, and Sales Team on day-to-day operational initiatives and execution. The Lab Director reports to the Chief Operating Officer and serves as the technical authority of the laboratory, focused on the science, quality, and regulatory integrity of all testing services.
Key Responsibilities:
Leadership
- Accessible to lab personnel at all times by providing on-site, telephone, or electronic support.
- Provide technical direction for all PCR and toxicology testing, including assay selection, validation, verification, and ongoing performance monitoring.
- Approve all test methods, standard operating procedures (SOPs), reference ranges, reportable ranges, and result interpretation criteria.
- Oversee method development, Laboratory Developed Test (LDT) validation, and implementation of new instruments and platforms.
- Review and approve quality control, calibration, and proficiency testing (PT) performance; ensure corrective actions are completed and documented.
- Serve as the technical resource for troubleshooting complex analytical issues, unusual results, and instrument or reagent performance concerns.
- Ensure patient test results are not reported until all corrective action has been taken, and the test system is functioning properly.
- Provide onboarding and orientation to all lab personnel.
- Participate in hiring and establish and monitor competency assessments, training, annual performance, and continuing education for all lab personnel.
- Foster a culture of accountability, scientific rigor, safety, and continuous improvement.
Regulatory Compliance and Quality
- Ensure continuous compliance with CLIA, CAP, COLA (if applicable), DEA, and state health department requirements.
- Lead readiness for and participation in all inspections, audits, and accreditation events; own corrective and preventive action (CAPA) responses.
- Maintain the laboratory’s quality management system, including document control, deviation management, internal audits, and competency assessments.
- Oversee proficiency testing enrollment, performance, and remediation.
- Ensure chain-of-custody integrity for toxicology specimens and adherence to forensic and clinical reporting standards as applicable.
Operational Oversight
- Provide oversight of daily lab operations to ensure turnaround time, accuracy, and capacity targets are consistently met.
- Review workflow performance, instrument utilization, and staffing models; recommend changes to improve throughput and quality.
- Support reagent, consumable, and instrument purchasing decisions in collaboration with the Chief Operating Officer.
- Support LIS configuration, test build, result reporting logic, and client system integrations.
- Assist with capacity planning, new panel feasibility analysis, and service expansion initiatives.
Client, Provider, and Cross-Functional Support
- Serve as the lab’s scientific point of contact for ordering providers, client accounts, and internal teams regarding test selection, methodology, and result interpretation.
- Support sales, account management, and client onboarding with technical documentation and expertise.
- Partner with billing and compliance teams to ensure accurate test coding, medical necessity documentation, and adherence to payer requirements.
Safety and Biosecurity
- Oversee laboratory safety programs, including chemical hygiene, biosafety, controlled substance handling, and waste management.
- Ensure proper handling, storage, and documentation of controlled substances in accordance with DEA requirements.
- Maintain a safe, compliant, and well-organized laboratory environment.
Qualifications and Education Requirements: (must have one of the following)
- Bachelor's degree in clinical laboratory science, medical technology, or chemical, physical, biological science AND 1 year training/experience in high complexity testing.
- Master’s degree in clinical laboratory science, medical technology, or chemical, physical, biological science AND 1 year training/experience in high complexity testing.
Experience:
- Minimum 7–10 years of progressive clinical laboratory experience, with at least 3–5years in a Director, Technical Director, or senior technical leadership role.
- Hands-on experience with PCR/molecular diagnostics.
- Hands-on experience with toxicology testing, including LC-MS/MS confirmation and immunoassay screening; familiarity with pain management, behavioral health, or addiction medicine workflows preferred.
- Proven success leading CLIA and CAP inspections with strong outcomes.
- Demonstrated experience validating Laboratory DevelopedTests and implementing new assays and instrument platforms.
- Prior supervisory experience over technical staff and laboratory supervisors.
Skills and Competencies:
- Deep knowledge of CLIA, CAP, HIPAA, OSHA, DEA, and applicable state regulations.
- Strong understanding of LIS systems, QC programs, PT management, and laboratory informatics.
- Working knowledge of revenue cycle implications related to test ordering, coding, and medical necessity.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent written and verbal communication; able to translate technical concepts for non-technical stakeholders.
- Collaborative leadership style with the ability to mentor and develop a high-performing technical team.
Work Environment:
- On-site role within an active clinical laboratory facility.
- Exposure to biological and chemical materials with appropriate PPE.
- Some off-hours availability may be required during inspections, validations, instrument go-lives, or operational escalations.
Success Measures:
- Maintain or achieve unconditional CLIA/CAP accreditation with zero major deficiencies.
- Sustain 100% acceptable proficiency testing performance across all analytes.
- Meet or exceed established turnaround time and accuracy targets for PCR and toxicology.
- Successfully validate and launch new assays or platforms in line with the operational roadmap.
- Establish and maintain a documented competency and training program for all testing personnel.
Pay: $115,000.00 - $125,000.00 per year
Benefits:
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Application Question(s):
- Confirm you understand this is not a Contractor, Remote or Hybrid position!
Education:
Experience:
- progressive clinical laboratory : 7 years (Required)
- Hands-on PCR/Molecular Diagnostics: 2 years (Required)
- Toxicology including LC-MS/MS Screening: 2 years (Required)
- Proven Success Leading CLIA and CAP Inspections: 1 year (Required)
Ability to Commute:
- Dallas, TX 75247 (Required)
Ability to Relocate:
- Dallas, TX 75247: Relocate before starting work (Required)
Work Location: In person
