Sr. Manager, Biomarker Operations

Moderna • Cambridge, MA

2d • $130,800 - $209,400 • Hybrid

About The Position

Moderna is seeking a Biomarker Operations Sr. Manager to support clinical teams and work across clinical trials with external biorepositories, assay laboratories, and CROs. The role collaborates across therapeutic area teams to ensure implementation, compliance, and support of biosample plans and management for Moderna clinical trials.

The position works in a 70/30 in-office model, with an emphasis on in-person collaboration. The role may involve access to technology or data subject to U.S. export control laws; employment is contingent on qualifying as a U.S. person under applicable U.S. law.

Requirements

• Bachelor’s degree in a life science-based subject.
• Minimum of 5 years of clinical research experience, including sponsor experience.
• Direct experience with clinical sample management.
• Solid understanding of GCP/ICH.
• Strong communication skills and attention to detail.
• Demonstrated ability to multitask.
• Must qualify as a U.S. person under U.S. export control requirements.

Nice To Haves

• Advanced degree.
• Prior process development experience.
• Familiarity with databases.

Responsibilities

• Independently support clinical teams in carrying out agreed-upon biomarker sample management plans for clinical trials.
• Lead review of biomarker sections of clinical protocols, clinical kit development, study and laboratory manuals, and consent forms.
• Promote process improvements for the clinical sample lifecycle.
• Lead development of processes and procedures for standardized language, biomarker usage, and data reporting.
• Support clinical teams to ensure biosamples comply with informed consent and GCP/ICH.
• Oversee clinical assay vendor logistics, including routine sample analysis meetings, addressing sample issues, and sample shipments.
• Lead efforts to resolve sample issues at central laboratories and third-party vendors.

Benefits

• Competitive healthcare and voluntary benefit programs.
• Well-being resources, including fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment programs to help employees plan for the future.
• Location-specific perks and extras.
• Potential eligibility for an annual discretionary bonus, other incentive compensation, or an equity award, subject to plan criteria and individual performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager