Associate Director, Assay Validation (Genomics)

TL;DR

Associate Director, Assay Validation (Genomics): Leading the planning, design, and execution of analytical validation studies for sequencing-based assays with an accent on CLIA, CAP, and NYS regulatory compliance. Focus on designing validation strategies for germline, somatic, and liquid biopsy applications to ensure clinical readiness and product launch.

Location: Must be based in Houston, TX (Hybrid setup involving office, remote, and laboratory environments)

Company

hirify.global is a clinical genomics company specializing in sequencing-based assays and genetic testing.

What you will do

• Lead the planning, design, and execution of analytical validation studies for NGS assays, including germline, somatic, and liquid biopsy applications.
• Develop validation strategies, protocols, and reports compliant with CLIA, CAP, and NYS quality standards.
• Collaborate with Bioinformatics, Quality, and Product teams to align validation strategy with assay design and clinical claims.
• Establish acceptance criteria, reference materials, and performance metrics to support validation activities.
• Serve as the subject matter expert for NGS validation methods and regulatory expectations.
• Mentor scientists and contribute to building a scalable validation function within the R&D organization.

Requirements

• PhD in Molecular Biology, Genetics, Genomics, or related field with 6+ years of experience, or M.S. with 8+ years.
• Proven track record leading validation of clinical NGS assays under CLIA, CAP, or NYS frameworks.
• Strong expertise in NGS library preparation, sequencing platforms, and assay performance characterization.
• Deep understanding of analytical validation parameters (accuracy, precision, limit of detection, specificity).
• Experience collaborating with bioinformatics teams for pipeline verification and integrated validation.
• Ability to work in a laboratory environment in Houston, TX.

Nice to have

• Experience with germline clinical genetic testing or prenatal liquid biopsy testing.
• Knowledge of NYS clinical test submission requirements or FDA IVD development processes.
• Experience managing a small team.
• Familiarity with automation or process scaling for NGS workflows.

Culture & Benefits

• Hybrid work environment allowing for a mix of office, remote, and laboratory work.
• Inclusive and diverse workplace culture as an equal opportunity employer.
• Opportunity to work with cutting-edge NGS technologies in a clinical R&D setting.