Associate Director, Clinical Biomarker Development

5 days ago

Cambridge, Massachusetts, United States Moderna Full time
Moderna is Seeking a Clinical Biomarker Lead

We are looking for a highly skilled and experienced Clinical Biomarker Lead to join our team at Moderna. As a key member of our Infectious Disease programs, you will be responsible for developing and driving biomarker plans across clinical stage programs.

Key Responsibilities:
  • Evaluate technologies to identify, define, and implement biomarker strategies to support clinical development of Moderna's vaccines.
  • Develop biomarker plans with input from research and clinical leads.
  • Manage biomarker assay labs to complete development, qualification, or validation studies.
  • Ensure timely and efficient delivery of biomarker operational aspects across vaccine clinical trials.
  • Develop and provide operational input and recommendations into study-related documentation and processes.
  • Serve as a single point of contact for biomarker operations across vaccine teams and with collaborators, assay labs, and CROs.
  • Responsible for identifying and selecting biomarker vendors in collaboration with Translational Science/Research leads.
  • Manage development and oversight of biomarker analysis timelines, budget, risk, and quality plans.
  • Attend operations team meetings and monitor training, CRO kick-off meetings, as applicable.
  • Participate in committees and work streams that support process and procedure for standardized language, biomarker usage, and data transfer and collection.
Requirements:
  • MS (with at least 8 years pharmaceutical/biotechnology experience) or PhD (with at least 2-4 years of pharmaceutical or biotechnology experience) in a related science focus.
  • Experience in clinical translational or biomarker work and its role across drug development from early phase through licensure.
  • Experience in Infectious disease programs is highly desirable.
  • Diagnostic assay development and testing experience is desirable.
  • Solid experience in the application of biomarkers during development of assets is preferred.
  • Experience in managing third-party assay laboratories, collaborations, and budget management.
  • Strong communication and project management skills.
About Moderna:

Moderna is a leading biotechnology company that is pioneering the use of mRNA technology to develop novel therapeutics and vaccines. We are committed to making a meaningful impact on the lives of patients and communities around the world. Our team is passionate about innovation, collaboration, and excellence, and we are seeking like-minded individuals to join our team.

We offer a comprehensive and innovative suite of benefits, including highly competitive medical, dental, and vision coverage options, flexible spending accounts, lifestyle spending account funds, family care benefits, and more. We are proud to be an equal opportunity workplace and are committed to diversity, equity, and inclusion.

Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Apply now to become a part of our team and help us change the future of medicine.

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