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Clinical Biomarkers Lead
2 months ago
SENIOR CLINICAL BIOMARKER MANAGER - ONCOLOGY
Hybrid Position: Onsite 2 Days Weekly
Contract Duration: 4 Months with Possibility of Extension
Role Overview:
We are looking for a Senior Clinical Biomarker Manager to spearhead the development and execution of biomarker strategies across various clinical stage oncology initiatives. This role requires collaboration with both internal teams and external contract research organizations (CROs) to ensure the effective 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: Proficiency in diverse biomarker assays, particularly in immuno-oncology, including but not limited to immunogenicity, immunophenotyping, TCR sequencing, and immunohistochemistry.
- CRO Management: Experience in managing clinical biomarker CROs, overseeing assay validation processes, and moderating data quality control from vendors.
- Regulatory Knowledge: Familiarity with GLP, GCLP, or CLIA standards.
- Clinical Trial Experience: Solid background in clinical trials.
Responsibilities:
- Utilize extensive knowledge and technical skills in various biomarker assays, particularly in the immuno-oncology field.
- Oversee the development and implementation of assays within the clinical biomarker team, collaborating with preclinical and clinical lab teams to assess current assay statuses and requirements.
- Manage vendor relationships to ensure timely and accurate task completion while addressing any arising issues.
- Provide operational insights and recommendations for all study-related documentation, ensuring compliance with GCP/ICH standards.
- Assist in evaluating biomarker vendors by leveraging technical expertise in biomarker assays.
Essential Requirements:
- PhD (with at least 1 year of pharmaceutical or biotechnology experience) or MS (with at least 6 years of pharmaceutical/biotechnology experience) in a relevant scientific discipline (e.g., immunology, oncology).
- Hands-on experience with biomarker assays, including cell-based immunogenicity assays, multiparametric flow cytometry, and multiplex cytokine assays.
- Experience in managing clinical biomarker CROs, with knowledge of biomarker assay qualification and validation requirements.
- Strong background in applying biomarkers during clinical development, including translational research and implementation in oncology.
- Excellent communication, organizational, and documentation skills.
