Labtopia, Inc.

JOB DESCRIPTION – Pharmacogenomic Laboratory Director (PGx) Testing

Location: Houston, TX

Position Overview

The Laboratory Director will serve as the highest-ranking scientific and technical authority in the laboratory, providing oversight of all pharmacogenomic testing operations in compliance with CLIA, CAP (if applicable), and CMS regulations. This individual will ensure the accuracy, reliability, and clinical relevance of all test results while maintaining the laboratory’s regulatory standing. The ideal candidate is a board-certified pathologist, clinical geneticist, or doctoral-level scientist with deep expertise in pharmacogenomics and molecular diagnostics.

Key Responsibilities

Regulatory Compliance & Laboratory Oversight

• Serve as the CLIA Laboratory Director, meeting all requirements under 42 CFR §493.1443 for high-complexity testing
• Ensure laboratory compliance with all applicable CLIA, CMS, CAP, and state-specific regulations
• Maintain and oversee the laboratory’s CLIA certificate and any additional accreditations
• Establish and enforce standard operating procedures (SOPs) for all PGx testing workflows
• Lead preparation for regulatory inspections and proficiency testing programs

Technical & Scientific Leadership

• Oversee validation, verification, and implementation of pharmacogenomic assays and panels
• Ensure accurate genotyping and phenotype interpretation for psychiatric medication metabolism (CYP2D6, CYP2C19, CYP3A4, CYP1A2, and related gene panels)
• Review and approve clinical test reports, including metabolizer status classifications

(poor, intermediate, normal/extensive, ultra-rapid)

• Evaluate emerging PGx biomarkers and recommend panel updates aligned with CPIC and DPWG guidelines

Quality Assurance & Quality Control

• Establish and monitor a comprehensive QA/QC program including proficiency testing, internal audits, and corrective action processes
• Review and resolve any quality deviations, non-conformances, or adverse events
• Ensure proper specimen handling, chain of custody, and documentation for all patient samples
• Monitor turnaround times and ensure timely delivery of test results to ordering providers
• Oversee molecular testing platforms (e.g., qPCR, microarray, NGS-based panels) and ensure instrument performance meets quality standards

Personnel & Training

• Supervise and provide technical guidance to laboratory technologists, technicians, and support staff
• Ensure all laboratory personnel meet CLIA qualification requirements for their respective roles
• Develop and oversee ongoing competency assessment and continuing education programs
• Participate in hiring decisions for laboratory personnel

Clinical Consultation & Collaboration

• Serve as a clinical resource for psychiatrists, prescribers, and mental health facility staff on PGx test interpretation
• Provide expert guidance on how genotype results translate to actionable prescribing recommendations
• Collaborate with the clinical team to develop educational materials for providers and patients
• Support Medicare Part B billing compliance by ensuring medical necessity documentation and proper coding

Required Qualifications

• Meet CLIA Laboratory Director qualifications under 42 CFR §493.1443 for high complexity testing
• Doctoral degree (MD, DO, PhD, or equivalent) in a relevant field such as pathology, clinical genetics, molecular biology, pharmacology, or clinical laboratory science
• Board certification in one or more of the following: Clinical Pathology (ABPATH), Molecular Genetics (ABMGG), Clinical Chemistry (ABCC), or equivalent
• Minimum 2 years of experience directing or supervising a clinical molecular or pharmacogenomic laboratory
• Demonstrated knowledge of pharmacogenomic testing methodologies and clinical applications in psychiatry/mental health
• Thorough understanding of CLIA, CMS, and CAP regulatory requirements
• Active, unrestricted state medical or professional license (if applicable)
• Experience with Medicare Part B laboratory billing(demonstrated experience with Z codes and CPT codes), compliance, and medical necessity requirements

Preferred Qualifications

• Specific expertise in pharmacogenomics
• Familiarity with CPIC guidelines, PharmGKB, and DPWG recommendations
• Experience with LIS/LIMS systems and laboratory information management
• Prior experience in a startup or growth-stage laboratory environment
• Experience with remote laboratory directorship models

Work Arrangement

This position can be structured as a full-time on-site role or a part-time/consultant arrangement with remote capabilities, depending on the candidate’s availability and qualifications. The Laboratory Director must be accessible for clinical consultations, quality review, and regulatory matters. On-site presence is required periodically for inspections, audits, and staff oversight.

• Due to the high-volume of applicants, only candidates who meet the requirements of the position will move through the interview process.
• This position does not offer C2C or H1-B sponsorship. Candidate acknowledges upon application that this position is not eligible for per diem or relocation reimbursement.