Sr. Manager, Biomarker Operations

The Role

Moderna is seeking a Biomarker Operations Sr. Manager to support the clinical teams and to work across its clinical trials as well as with external biorepositories, assay laboratories and CROs. This position will work collaboratively across all therapeutic area teams to ensure implementation, compliance and support of biosample plans and management for clinical trials conducted by Moderna.

Here's What You'll Do

• Independently support to the clinical teams driving agreed upon biomarker sample management plans for the clinical trials
• Lead the review of biomarker sections of clinical protocols, clinical kit development, study/lab manuals and consent forms
• Promote process improvements for clinical sample lifecycle
• Lead the development of processes and procedures for standardized 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

Here's What You'll Bring to the Table

• Bachelor's degree in a life science-based subject; advanced degree preferred
• Minimum of 5 years of clinical research experience which must include 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

Our Working Model

• As we build our company, we have always believed an in-person culture is critical to our success.
• Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model.
• This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship.
• Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That's why our benefits and well-being resources are designed to support you-at work, at home, and everywhere in between.

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

• The salary range for this role is $130,800.00 - $209,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting.
• An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.
• The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.