Senior Scientist, Translational Biomarkers

Role Summary

Senior Scientist, Translational Biomarkers

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.
• Responsible for ensuring 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.
• Analyze, interpret, prepare and present data summaries, communicate next steps and provide recommendations to internal teams and stakeholders.
• Contribute to regulatory document preparation.
• 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 used to support early to late phase clinical trials.
• Strong technical expertise in developing, validating and implementation of clinical biomarker, immunological, molecular and gene expression assays.
• 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 a demonstrated understanding of ICH/GCP and regulatory requirements.
• Strong problem-solving skills and ability to independently oversee scientific projects, rigorously analyze and interpret scientific data while maintaining 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.