Key responsibilities:
The clinical genomics research scientist is responsible for helping to development clinical genomic workflows and perform genomic and genetic testing of clinical trial biospecimens to advance translational research initiatives. This includes but is not limited to responsibilities for genomics and gene expression profiling (GEP) biomarker assay technology/ platform selection, evaluation of in-house or vendor choice per assay use requirements, development, optimization, qualification/validation and execution of biomarker analysis for translational medicine and clinical programs. Successful candidates must have a strong technical background in genomics and transcriptomics and its application in clinical programs, additional specific requirements listed below:
• Developing genomics and transcriptomics strategies with biomarker leads, data analysis, and trial operations teams.
• Focusing 100% on lab work, requiring onsite attendance.
• Designing and developing genomics/transcriptomics assays, including broad genomic/GEP profiling, pharmacodynamic, target engagement, predictive, and prognostic assays.
• Developing, optimizing, qualifying/validating, and executing biomarker assays, both in-house and with external vendors.
• Overseeing assay/workflow development and analyzing qualification/validation data.
• Providing subject matter expertise and oversight for outsourced studies.
• Drafting experimental plans, qualification protocols, reports, SOPs, technology transfer documents, and study summaries.
• Participating in internal/external collaborations and clinical study teams.
• Assessing and onboarding relevant technologies through due diligence and pilot projects.
• Working closely with data analysis, sample management, and clinical operation teams.
• Providing mentorship and leadership within the lab team.
• Developing efficient genomics processes and best practices.
Education and Experience:
• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’)
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
• OR PhD
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
• Prior experience working in a CLIA-licensed lab is a plus.
• Must be capable of working and operating in a laboratory environment for the entirety of the work schedule.
• Significant experience with NGS or GEP applications is required.
• Demonstrated experience in assay development for genomics assets, preferably in a pharma, biotech, diagnostic, or clinical lab setting.
• In-depth, hands-on experience with genomics platforms (NGS, qPCR, variant analysis) for assay development, qualification/validation, troubleshooting, and reviewing run QC data.
• Experience with technologies for ctDNA and GEP analysis is critical.
• Understanding of fit-for-purpose genomics assay validation principles for clinical assays.
• Knowledge of clinical sample analysis regulatory and quality frameworks (e.g., GCP, CLIA, CAP, NYDOH) is a plus.
• Strong organizational and collaborative skills are essential.
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