Senior Clinical Biomarker Manager
2 weeks ago
SENIOR CLINICAL BIOMARKER MANAGER - ONCOLOGY
Hybrid Position: Onsite 2 Days Per Week
Contract Duration: 4 Months with Possibility of Extension
Role Overview:
We are seeking a Senior Clinical Biomarker Manager to spearhead the development and execution of biomarker strategies across clinical-stage oncology initiatives. This role involves close collaboration with both internal teams and external contract research organizations (CROs) to ensure the meticulous planning, execution, and delivery of biomarker laboratory data for clinical trials.
Key Qualifications:
- Experience: Proven track record in a pharmaceutical or biotechnology environment.
- Education: PhD with a minimum of 1 year of relevant experience or MS with at least 6 years of industry experience.
- Technical Skills: In-depth knowledge of various biomarker assays, particularly in immuno-oncology, including but not limited to immunogenicity, immunophenotyping, TCR sequencing, and immunohistochemistry.
- CRO Management: Experience managing clinical biomarker CROs, focusing on assay validation and data quality control.
- Regulatory Knowledge: Familiarity with GLP, GCLP, or CLIA standards.
- Clinical Trial Experience: Demonstrated involvement in clinical trials.
Responsibilities:
- Leverage extensive knowledge and technical expertise in biomarker assays to guide the clinical biomarker team.
- Oversee the development and implementation of assays by collaborating with preclinical and clinical biomarker laboratory teams to assess current assay capabilities and vendor requirements.
- Ensure timely and accurate task completion by managing vendor relationships and addressing any arising issues.
- Provide operational insights and recommendations for all study-related documentation, ensuring compliance with GCP/ICH standards.
- Contribute technical expertise to the evaluation of biomarker vendors.
Essential Requirements:
- PhD (with at least 1 year of relevant experience) or MS (with at least 6 years of relevant experience) in a scientific discipline such as immunology or oncology.
- Hands-on experience with biomarker assays, including cell-based immunogenicity assays and multiparametric flow cytometry.
- Experience in managing clinical biomarker CROs and knowledge of assay qualification/validation in regulated environments.
- Solid background in applying biomarkers during clinical development, including translational research and biomarker implementation in oncology.
- Excellent communication, organizational, and documentation skills.
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