Sr. Manager, Biomarker Operations

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

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.

About Moderna

Since our founding in 2010, we have aspired 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. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our 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.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Equal Opportunities

Moderna is 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.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day,

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [e-mail].

Export Control NoticeThis position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.#LI-NH1

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.