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Lead Clinical Biomarker Manager
2 months ago
Position Overview:
Randstad USA is seeking a Senior Manager of Clinical Biomarkers to spearhead the development and execution of biomarker strategies across clinical oncology initiatives. This role is pivotal in collaborating with both internal teams and external partners to ensure the successful delivery of biomarker data for clinical trials.
Key Responsibilities:
- Utilize extensive knowledge and technical skills in various biomarker assays, particularly in the field of immuno-oncology, including but not limited to immunogenicity, immunophenotyping, TCR sequencing, and immunohistochemistry.
- Manage assay development and implementation by working closely with preclinical and clinical biomarker laboratory teams to assess current assay capabilities and identify requirements for oncology projects.
- Oversee vendor relationships to ensure timely and precise task completion while addressing any issues that may arise during the process.
- Provide operational insights and recommendations for all study-related documentation, ensuring compliance with GCP/ICH standards for the collection, delivery, and analysis of biological samples.
- Contribute technical expertise in biomarker assays during the evaluation of biomarker vendors.
Qualifications:
- PhD with a minimum of 1 year of experience in the pharmaceutical or biotechnology sector, or an MS with at least 6 years of relevant experience in a scientific discipline such as immunology or oncology.
- Demonstrated hands-on experience with biomarker assays, including cell-based immunogenicity assays and multiparametric flow cytometry.
- Proven experience in managing clinical biomarker CROs, with a solid understanding of biomarker assay qualification and validation requirements.
- Strong background in the application of biomarkers within clinical development, particularly in oncology.
- Excellent communication, organizational, and documentation skills are essential.
