Director, Clinical Genomics & Molecular Assay Development

Position Summary Director, Clinical Genomics & Molecular Assay Development (MAD) Key Responsibilities 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. Qualifications & Experience 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. Compensation & Benefits (if eligible) 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). #J-18808-Ljbffr