Associate Director, Assay Validation (Genomics)

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.