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.
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