Senior Scientist, Translational Biomarkers

Role Summary

Senior Scientist, Translational Biomarkers will design, develop and validate biomarker assays to support clinical safety and efficacy studies; ensure regulatory compliance with ICH Q2 guidelines; manage transfer and validation of biomarker assays at CROs; contribute to translational plans addressing MOA, pharmacokinetics and pharmacodynamics; collaborate with Clinical Operations, Data Management and Biometrics to advance data acquisition and analyses; oversee scientific projects and potentially supervise associate scientists.

Responsibilities

• Design, develop, validate and execute robust fit-for-purpose clinical biomarker assays to support secondary and exploratory endpoints in clinical safety and efficacy studies.
• Ensure biomarker methods are compliant with ICH Q2 guidelines and meet regulatory standards.
• Manage the transfer, bridging and validation of biomarker assays at CROs.
• Contribute to biomarker plans and strategies for addressing key translational questions such as MOA, pharmacokinetics and pharmacodynamics of drug candidates.
• Collaborate with external partners, Clinical Operations, Clinical Data Management and Biometrics to advance data acquisition and analyses of clinical trial data.
• Analyze, interpret, prepare and present data summaries, communicate next steps and provide recommendations to internal teams and stakeholders.
• Contribute to regulatory document preparation such as clinical protocol, regulatory responses, and submissions.
• Identify, evaluate and integrate new technologies to support evolving translational biomarker strategies.
• Write and review SOPs, technical protocols and reports.
• May supervise associate scientists and support their professional development.

Qualifications

• PhD in immunology, immuno-oncology, molecular and cellular biology or related field.
• 5+ years of biomarker experience in the pharmaceutical industry.
• Strong understanding of various technology platforms and datasets used to support clinical biomarker assays for early to late-phase clinical trials.
• Strong technical expertise in developing, validating and implementing clinical biomarker, immunological, molecular and gene expression assays including multi-parameter flow cytometry (>12 colors), immunohistochemistry (IHC), droplet digital PCR (ddPCR), RNA isolation/sequencing, gene expression with platforms such as Nanostring.
• Subject Matter Expert (SME) on validation of analytical methods per ICH Q2 guidelines.
• Strong data analysis capabilities of high-dimensional data using FlowJo or data packages such as Cytobank; knowledge of R and/or Python is preferred.
• Experience managing CROs and ensuring high-quality, timely delivery of biomarker data, with understanding of ICH/GCP and regulatory requirements.
• Strong problem-solving skills and ability to independently oversee scientific projects, rigorously analyze and interpret scientific data with attention to detail.
• Effective communication skills, with the ability to present complex data to diverse audiences.
• Experience working in a GCLP regulated environment and extensive knowledge of GLP/GCP compliant studies.

Skills

• Biomarker assay development and validation
• Immunology and immuno-oncology techniques
• Flow cytometry (multi-parameter)
• Immunohistochemistry (IHC)
• ddPCR and nucleic acid analysis
• RNA sequencing and gene expression platforms (e.g., Nanostring)
• Analytical method validation and regulatory compliance (ICH Q2)
• Data analysis in high-dimensional datasets (FlowJo, Cytobank; R/Python preferred)
• Project management and CRO oversight
• Scientific communication and cross-functional collaboration