Associate Director, Clinical Product Development
Adaptive Biotechnologies Corp.
5 months ago
On-site
Seattle, WA
Clinical Research and Development
Associate Director, Clinical Product Development (CPD)
Responsibilities
- Lead a multi-functional team to develop and validate clinical diagnostic assays from concept through launch.
- Drive assay development/optimization and verification/validation (V&V), including technical feasibility, methods development, design risk management, QC criteria, and end-to-end robustness.
- Provide scientific leadership on experimental design/planning, data analysis/review, and data summarization/presentation (with Computational Biology/Biostatistics).
- Support product pipeline strategy by expanding clinical use cases and/or evaluating new technology platforms.
- Partner with Technical Clinical Operations for design specification handoff and design transfer to Clinical Laboratory Operations and Manufacturing.
- Define development scope, deliverables, milestones, dependencies, and oversee execution.
- Author/review design control and risk management documents (e.g., DHF, requirements/specifications, FMEA) to support IVD products.
- Provide project status/timeline updates to senior leadership; mentor managers and support team performance and career development.
Required Qualifications
- PhD in molecular genetics, immunology, bioengineering, or related field; 8+ years assay R&D (MS 10+; BS 12+).
- 4+ years in a diagnostic/medical device/life sciences company.
- 4+ years supervisory experience.
Preferred Qualifications
- Proven assay development leadership; expertise in molecular biology/genomics/multiplex PCR/NGS, sequencing data analysis, and statistical analysis.
- Experience developing IVD or CLIA assays under design control (FDA 21 CFR 820, ISO 13485, ISO 14971; and/or CLIA/CAP, CLEP); familiarity with CLSI.
- Regulatory experience (e.g., FDA, Notified Bodies).
- Experience in hematology/oncology/immunology with NGS; statistical analysis (sampling plans, power analysis; e.g., JMP/R); project management leadership; strong technical writing and communication.
Compensation/Benefits
- Salary range: $144,600–$217,000.
- Equity grant; bonus eligible.
Working Conditions
- Office environment; occasional lab work with human biological specimens; flexibility for nights/weekends; travel to corporate/conferences/customer meetings as needed.
Responsibilities
- Lead a multi-functional team to develop and validate clinical diagnostic assays from concept through launch.
- Drive assay development/optimization and verification/validation (V&V), including technical feasibility, methods development, design risk management, QC criteria, and end-to-end robustness.
- Provide scientific leadership on experimental design/planning, data analysis/review, and data summarization/presentation (with Computational Biology/Biostatistics).
- Support product pipeline strategy by expanding clinical use cases and/or evaluating new technology platforms.
- Partner with Technical Clinical Operations for design specification handoff and design transfer to Clinical Laboratory Operations and Manufacturing.
- Define development scope, deliverables, milestones, dependencies, and oversee execution.
- Author/review design control and risk management documents (e.g., DHF, requirements/specifications, FMEA) to support IVD products.
- Provide project status/timeline updates to senior leadership; mentor managers and support team performance and career development.
Required Qualifications
- PhD in molecular genetics, immunology, bioengineering, or related field; 8+ years assay R&D (MS 10+; BS 12+).
- 4+ years in a diagnostic/medical device/life sciences company.
- 4+ years supervisory experience.
Preferred Qualifications
- Proven assay development leadership; expertise in molecular biology/genomics/multiplex PCR/NGS, sequencing data analysis, and statistical analysis.
- Experience developing IVD or CLIA assays under design control (FDA 21 CFR 820, ISO 13485, ISO 14971; and/or CLIA/CAP, CLEP); familiarity with CLSI.
- Regulatory experience (e.g., FDA, Notified Bodies).
- Experience in hematology/oncology/immunology with NGS; statistical analysis (sampling plans, power analysis; e.g., JMP/R); project management leadership; strong technical writing and communication.
Compensation/Benefits
- Salary range: $144,600–$217,000.
- Equity grant; bonus eligible.
Working Conditions
- Office environment; occasional lab work with human biological specimens; flexibility for nights/weekends; travel to corporate/conferences/customer meetings as needed.