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Janux Therapeutics

Posted 6 months ago

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Clinical Biomarker Lead

San DiegoOn-siteFull-time

AI Summary

Leads end-to-end clinical biomarker strategy and execution for early-stage oncology and autoimmune programs, managing datasets, analytics, vendor labs, and cross-team collaboration.

About this role

Janux Therapeutics is seeking a Clinical Biomarker Lead to join our Translational group and contribute to the end-to-end planning and execution of clinical biomarker strategy for our early-stage clinical programs. This individual will closely work with the biomarker operations and research team to ensure timely clinical sample evaluation and generate data analytics strategy to derive critical insights from clinical trial data to inform strategic decision-making. The ideal candidate will bring an in-depth understanding of oncology and/ or immunology and clinical-translational research experience.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

  • Lead end-to-end execution of the clinical biomarker strategy to support Janux’s oncology and autoimmune clinical programs
  • Organize and maintain clinical biomarker and bioanalytical datasets and individual patient profiles for clinical programs.
  • Perform high throughput data analytics of, translational, and clinical datasets to identify and validate potential biomarkers of response/resistance to TRACTr, TRACIr, and/or ARM treatments.
  • Integrate functional biological readouts with patient’s clinicopathological features to contribute to patient selection strategies for clinical programs.
  • Collaborate with Biomarker and clinical operation teams to ensure end-to-end sample tracking and maintain oversight on all sample related timelines including subsequent data collection and distribution.
  • Manage multiple specialty vendor labs and maintain strong oversight on deliverables (proposals, timelines, experimental design, data analyses and reporting).
  • Prepare and present data. Collaborate with internal Clinical Science and Research/ Immunology teams to evaluate data analytic approaches and ensure meaningful insights in the delivery. Perform in-depth scientific literature review to help address critical questions relating to target biology, clinical relevance, and associated assays.
  • Work cross-functionally with Research, Clinical and CMC teams to drive scientific programs and deliver critical insights to help inform decision-making across the portfolio.

    • EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

  • Ph.D. in Immunology, Clinical/Health Sciences, Bioinformatics, or related scientific discipline with 4+ years of experience, preferably in an industry setting, with an emphasis in clinical biomarker analysis or translational medicine.
  • Strong understanding and experience working in immuno-oncology and/or solid tumor oncology with hands-on experience in designing, developing, and interpreting clinical biomarker datasets.
  • Competence with data analysis tools (Excel, GraphPad). Proficiency in data handling and visualization with R or Python is preferred.
  • Demonstrated ability to create impactful data visualization outputs and present meaningful insights.
  • Experience working with EDC systems and data listings is highly preferred.
  • Experience with Good Clinical Practice (GCP) principles and studies transitioning into clinical trials.
  • Experience working with external CROs (due diligence, proposals, oversight, project management, data analyses, and reporting) is highly preferred.
  • Strong analytical and critical thinking skills with the ability to work in a fast-paced environment. Excellent written and oral communication skills.

    • Skills

    Biomarker AnalysisClinical-translational ResearchCRO Vendor ManagementData VisualizationEDC SystemsExcelGCPGraphPadPythonR

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