Director, Clinical Genomics & Molecular Assay Development
Bristol Myers Squibb
3 days ago
Remote friendly (Princeton, NJ)
United States
Clinical Research and 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).
Application Instruction
- If the role doesn’t fully match your resume, apply anyway.
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).
Application Instruction
- If the role doesn’t fully match your resume, apply anyway.