Senior Biomarker Operations Leader

Moderna; Cambridge (MA); Hybrid; USD 131,000 - 209,000; Full time

Benefits offered by this job

Competitive healthcare, plus voluntary

Holistic well-being program

Family planning benefits, including (

Generous paid time off, includingvac,

Job summary

Moderna is seeking a Biomarker Operations Sr. Manager to support clinical teams and collaborate with biorepositories, assay labs and CROs across trials.

This role will drive biomarker sample management plans, review protocol sections, and lead process improvements in the sample lifecycle while ensuring GCP/ICH compliance and informed consent requirements. The role emphasizes cross-functional partnership and data reporting across therapeutic areas.

Qualifications

• Bachelor’s degree in a life science subject; advanced degree preferred
• Minimum of 5 years of clinical research experience including sponsor experience
• Direct experience with clinical sample management
• Prior process development experience is very helpful
• Familiarity with databases is helpful
• Solid understanding of GCP/ICH is required
• Strong communication skills and attention to detail
• Demonstrated ability to multitask

Responsibilities

• Independently support clinical teams with biomarker sample management plans for trials
• Lead review of biomarker sections in protocols, clinical kit development, study/lab manuals and consent forms
• Promote process improvements for the clinical sample lifecycle
• Lead development of procedures for standardized biomarker language, biomarker usage, and data reporting
• Support clinical teams to ensure biosamples are compliant with informed consent and GCP/ICH
• Oversee clinical assay vendor logistics (routine sample analysis meetings, address sample issues, sample shipments)
• Lead efforts to resolve sample issues at Central Labs and 3rd-party vendors

Skills

Biomarker sample management

Clinical trial experience

GCP/ICH knowledge

Process development

Database familiarity

Communication skills

Multitasking

Vendor logistics

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Job description

Moderna is seeking a Biomarker Operations Sr. Manager to support clinical teams and collaborate with biorepositories, assay labs and CROs across trials.

This role will drive biomarker sample management plans, review protocol sections, and lead process improvements in the sample lifecycle while ensuring GCP/ICH compliance and informed consent requirements. The role emphasizes cross-functional partnership and data reporting across therapeutic areas.