Senior Manager, Clinical Biomarkers, Oncology

23 hours ago


Cambridge, Massachusetts, United States Moderna Therapeutics Full time
About the Role

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.
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 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.
About Moderna

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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