Director, Clinical Genomics & Molecular Assay Development

Position Summary

Director, Clinical Genomics & Molecular Assay Development (MAD)

• Provide strategic leadership and accountability for clinical genomics, transcriptomics, and molecular assay strategies across translational medicine and clinical development.
• Lead genomics biomarker strategy with program biomarker leads, data analysis, and clinical operations; align assay plans with protocol needs, program biology, and mechanism of action.
• Oversee assay/platform selection for genomic profiling, gene expression, pharmacodynamic/target engagement, predictive/prognostic, genotyping, ctDNA, and variant analysis.
• Direct NGS/PCR/qPCR assay design, development, optimization, qualification, validation, and lifecycle management.
• Manage lab scientist direct reports; ensure quality outputs and on‑time data delivery.
• Maintain hands‑on laboratory presence and core lab operational support.
• Drive innovation by evaluating and implementing emerging genomics technologies.
• Provide strategic oversight for internal and outsourced assay execution (vendor selection; scientific oversight of assay development and clinical sample testing; author/review experimental plans, validation reports, work instructions, tech transfer docs, study summaries, SOPs; troubleshoot performance; establish controls/QC).
• Partner cross‑functionally to define data structure, QC review, interpretation, and delivery of results.
• Serve as genomics subject matter expert; lead/mentor teams and build lean genomics processes.

• BS with 15+ years (or MS with 12+ years, or PhD/equivalent with 8+ years) in molecular biology/genomics/biochemistry/chemistry or related life science.
• 6+ years leadership experience.
• Demonstrated success leading clinical genomics/transcriptomics strategy for translational and/or clinical‑stage programs.
• Deep expertise in NGS, qPCR/PCR, gene expression profiling, genotyping, ctDNA, and variant analysis (development, troubleshooting, QC).
• Preferred: fit‑for‑purpose assay validation knowledge in regulated labs (FDA, CAP, CLIA, ACMG, NYSDOH, and others).
• Proven ability to lead regulated assay work with vendors/CROs.
• Expertise in data structures, assay QC, and genomics dataset interpretation.
• Excellent communication; experience authoring validation plans/reports, study summaries, tech transfer docs, and SOPs.

• Princeton, NJ: $217,960–$264,113; additional incentive cash/stock may be available.
• Benefits include medical/dental/vision, wellbeing programs, and financial protection (e.g., 401(k), disability, life insurance).
• Paid time off includes flexible time off (exempt) and national holidays (specifics vary by location).