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  • Principal Scientist

    BeOne Medicines (San Carlos, CA)



    Apply Now

    General Description:

    We are seeking a Clinical Biomarker Scientist to lead biomarker strategy and execution in clinical studies. 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 will have a strong background in translational research, a deep understanding of clinical biomarkers, and excellent communication skills to drive insights that support clinical decision making and advance drug development.

    Essential Functions of the job:

    + 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’s continuous improvement and innovation.

    Qualifications:

    + 3+ years of experience with PhD in Life Science (e.g., Immunology, Molecular & Cellular Biology, Biochemistry, 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.

    + Deep understanding of immunological mechanisms, 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.

     

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

     


    Apply Now



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