- Lead an assay development team from project inception through launch including sample selection, hands-on laboratory validation, establishing workflow and SOPs, and authoring validation plans and summaries
- Ensure projects are completed within aggressive timelines and respond appropriately to changing priorities
- Facilitate smooth transfers of developed workflows into clinical lab environments
- Evaluate emerging molecular and sequencing technologies and align these to business initiatives and product portfolio needs
- Mentor project leads and scientific staff on experimental design, continuous learning and time management
- Provide flexible support for other activities in the clinical Next Generation Sequencing lab, including emerging technology assessment, LIMS consulting, instrument troubleshooting, etc.
- Master's with 15+ years or Ph.
- A deep technical understanding of NGS assays and sequencer platforms with the ability to assess new technologies to drive innovation within a molecular assay pipeline
- Specific experience with high-sensitivity NGS applications suitable for liquid biopsy applications
- Experience with liquid biopsy applications in oncology from plasma-derived cf/ctDNA and/or CTCs
- Experiencing development clinical assays and understanding of GCP/GCLP, CLIA/CAP, ISO13485/15189, and other regulatory guidelines
- Experience leading small teams in a fast-paced and dynamic environment as well as the ability to build teams to align to organizational objectives
- Ability to work closely with cross-functional team leads in engineering, bioinformatics, operations, and pathology to develop and validate NGS assays
- Ability to manage multiple projects and work streams across the Labs development team, including assessment of workload and resourcing requirements to deliver the teams objectives
- Strong track record of assay and/or product development
- Thrives in a fast-paced environment
- Experience with robotics and automated liquid handling systems
- Knowledge of design controls for IVD development
- Knowledge of LIMS platforms and various computer systems
- Strong professional network with leaders in one or more of the following areas: liquid biopsy oncology, NGS reagent development, NGS instrument development.
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Senior Director, NGS Liquid Biopsy - Chicago, United States - Tempus
Description
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way.
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
We are looking for a Senior Director of NGS Liquid Biopsy to support our growth in molecular oncology assays.You will build and lead the group responsible for developing cutting-edge tumor profiling, minimal residual disease detection, and early cancer detection clinical NGS and molecular assays.
This role requires someone who will maintain a knowledge base of cutting-edge developments in molecular techniques and NGS platform developments to enable the evolution of Tempus's assays to lead in a competitive market landscape.
In addition to product development, you will be responsible for ongoing continuous improvement and industrialization of our liquid biopsy NGS and molecular assays.
Finally, you will collaborate cross-functionally with data product engineers to define product, data, and quality requirements to position assays well for secondary algorithm development in AI-assisted discovery across integrated data structures.
What You'll Do:
Qualifications:
Highly Desirable:
We are an equal opportunity employer.
We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.