Clinical Biomarker Lead

4 days ago

Cambridge, Massachusetts, United States Moderna Full time
The Role:

Moderna is seeking a highly skilled Clinical Biomarker Lead to develop and drive biomarker plans across clinical stage Infectious Disease programs. This position reports to Moderna's Director of Infectious Disease, Clinical Biomarkers.

Key Responsibilities:
  • Evaluate technologies to identify, define, and implement the biomarker strategy to support the 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 to execute the clinical biomarker plan on time and with good quality.
  • Ensure timely and efficient delivery of all biomarker operational aspects across vaccine clinical trials, accountable for planning, coordinating, and overseeing all operational activities required to manage the flow of biomarker samples from planning, collection, analysis, data delivery, and final sample disposition with support from the Biosample Operations Manager.
  • Develop and provide operational input and recommendations into all study-related documentation (including protocol, lab manual, informed consent form, and amendments) and processes, ensuring collection, delivery, and analysis of biosamples in compliance with these documents as well as GCP/ICH.
  • Serve as a single point of contact for biomarker operations across vaccine teams and with collaborators, assay labs, and CROs.
  • Manage the 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, to deliver trainings on biomarker activities.
  • 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 (i.e., immunology, molecular biology, biotechnology).
  • Experience in clinical translational or biomarker work and its role across drug development from early phase through licensure.
  • Experience in Infectious disease programs (Ex: Human respiratory viruses / Human herpes viruses / HIV / Human Flaviviruses / Bacterial diseases) is highly desirable.
  • Diagnostic assay development and testing experience is desirable.
  • Solid experience in the application of biomarkers during development of assets is preferred, including experience with clinical translational research, validation, and implementation.
  • 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 aspires to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. 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.

We are committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.

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