Associate Director Clinical Biomarker

1 week ago


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

We are looking for a highly skilled Clinical Biomarker Lead to join our team at Moderna. As a key member of our Infectious Disease program, 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.
  • 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.
  • Identify and select biomarker vendors in collaboration with Translational Science/Research leads.
  • Manage 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 creating a culture of belonging and building an organization that cares deeply for our patients, employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

As a member of our team, you will have the opportunity to work on cutting-edge projects, collaborate with talented colleagues, and contribute to the development of innovative therapies and vaccines.



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