Senior Manager, Clinical Biomarkers, Oncology
23 hours ago
Moderna is seeking a highly skilled Senior Manager, Clinical Biomarkers to lead the development and implementation of biomarker plans across clinical stage Oncology programs.
Key Responsibilities- Develop and drive biomarker plans to support Oncology clinical trials, collaborating with internal and external teams to ensure planning, execution, and data delivery.
- Oversee assay development and implementation efforts, partnering with preclinical and clinical biomarker lab teams to understand current assay status and vendor or internal laboratory requirements.
- Manage vendors to ensure timely and accurate completion of tasks, troubleshooting issues as they develop.
- Provide operational input and recommendations into study-related documentation, ensuring compliance with GCP/ICH and relevant regulations.
- Contribute to the evaluation of biomarker vendors, providing technical expertise in biomarker assays.
- PhD (with at least 1 year of pharmaceutical or biotechnology experience) or MS (with at least 6 years of pharmaceutical/biotechnology experience) in a related science focus.
- Hands-on experience with biomarker assays, including cell-based immunogenicity assays, multiparametric flow cytometry, and immunohistochemistry.
- Experience in clinical biomarker CRO management and knowledge of relevant biomarker assay qualification/validation requirements.
- Strong communication, organization, and record-keeping skills.
Moderna is a leading biotechnology company pioneering messenger RNA (mRNA) technology to create innovative medicines. We are committed to transforming the lives of patients and their families through our work.
We offer a comprehensive benefits package, including medical, dental, and vision coverage, flexible spending accounts, and a generous paid time off policy. Our team is passionate about making a difference in the world, and we invite you to join us on this journey.
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Senior Manager, Oncology Clinical Biomarkers
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