Clinical Biomarker Lead

Role Summary

Clinical Biomarker Lead to join the Translational group and contribute to the end-to-end planning and execution of clinical biomarker strategy for early-stage clinical programs. The role collaborates with biomarker operations and research teams to ensure timely clinical sample evaluation and to generate data analytics strategies that derive critical insights from clinical trial data to inform strategic decision-making. Ideal candidate has deep understanding of oncology and/or immunology and clinical-translational research experience. Location: On site in San Diego, CA.

Responsibilities

• Lead end-to-end execution of the clinical biomarker strategy to support 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 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 oversight of all sample-related timelines including data collection and distribution
• Manage multiple specialty vendor labs and oversee 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; perform literature reviews to address questions related to target biology, clinical relevance, and assays
• Work cross-functionally with Research, Clinical and CMC teams to drive scientific programs and deliver insights to inform decision-making across the portfolio

Qualifications

• Ph.D. in Immunology, Clinical/Health Sciences, Bioinformatics, or related scientific discipline with 4+ years of experience, preferably in industry, in clinical biomarker analysis or translational medicine
• Strong understanding and experience 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 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 ability to work in a fast-paced environment; excellent written and oral communication skills

Education

• Ph.D. in Immunology, Clinical/Health Sciences, Bioinformatics, or related field