Principal Scientist, Clinical Biomarker Hematology

Role Summary

Principal Scientist, Clinical Biomarker Hematology. BeOne seeks a Clinical Biomarker Scientist to lead biomarker strategy and execution in clinical studies, with a focus on hematology-related biomarkers. The role involves designing and analyzing biomarker studies, collaborating with cross-functional teams, and managing external CROs to ensure high-quality data delivery. The ideal candidate has a strong background in translational research, experience with high dimensional flow cytometry and data analysis, and a deep understanding of clinical biomarkers to drive insights that support clinical decision making and drug development.

Responsibilities

• Serve as the primary biomarker scientist for the clinical study team, ensuring biomarker strategies are integrated into clinical development plans.
• Deliver robust biomarker strategies at the study level, including target engagement, pharmacodynamics endpoints, patient selection and companion diagnostic development (if appropriate).
• Align biomarker strategies with clinical operational plans and functional area capabilities to ensure seamless execution.
• Author and edit biomarker sections of clinical protocols, ensuring scientific accuracy and clarity.
• Oversee the implementation of biomarker plans, including sample collection, alignment with consent forms, Human Biological Sample Management, and adherence to protocol and data standards.
• Collaborate with and manage external vendors and collaborators involved in clinical studies or translational research, including vendor evaluation and selection for biomarker activities.
• Evaluate and integrate emerging technologies into clinical studies, working closely with statisticians, bioinformatics teams, clinical and translational groups to address biomarker needs.
• Lead the analysis and summarization of study specific biomarker data, presenting findings and strategic recommendations to internal and external stakeholders.
• Stay informed on emerging scientific and technological advancement, contributing to the group‚Äôs continuous improvement and innovation.

Qualifications

• 3+ years‚Äô experience, with PhD in Life Science (e.g., Immunology, Molecular & Cellular Biology, or related fields), with a strong emphasis on immunology research and its application to translational science.
• Demonstrated experience in clinical biomarkers and translational research in a pharmaceutical or biotech industry, particularly in Immunology, Oncology, or hematology.
• Technical know how in flow cytometry and experience in working with complex data types such as flow and scRNAseq
• Deep understanding of immunological mechanisms (i.e., NK and T cell biology), immune-related biomarkers, and their role in clinical drug development.
• Familiarity with the operational aspects of implementing biomarker strategies in clinical development is highly desirable.
• Proven ability to collaborate within cross-functional, international teams and thrive in a fast-paced dynamic environment.

Skills

• Biomarker strategy development
• Clinical study design and protocol authoring
• Sample management and data standards
• Vendor management and cross-functional collaboration
• Data analysis for biomarkers, including flow cytometry and scRNA-seq
• Emerging technologies in translational science

Education

• PhD in Life Science or related field (Immunology, Molecular & Cellular Biology, or related)

Additional Requirements

• None beyond listed qualifications; travel not specified.