Manager, Biomarker Operations

RXinsider LTD.; Cambridge, Northern (MA, KY); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Paid time off

Job summary

Moderna is seeking a Biomarker Operations Manager to support biomarker and clinical teams across its clinical trials and external collaborations. The role ensures compliant biosample plans, management, and reporting for trials conducted by Moderna.

You will lead cross-functional efforts in protocol review, central lab specifications, and process improvements for the biomarker lifecycle, with an emphasis on GCP/ICH compliance and clear data reporting.

Qualifications

• Bachelor's degree in life sciences or related field.
• Minimum 5 years clinical research experience including sponsor interactions.
• Direct experience with clinical sample management.
• Familiarity with Excel is essential.
• Solid understanding of GCP/ICH requirements.
• Strong communication skills and attention to detail.

Responsibilities

• Implement clinical biomarker sample management plans across Moderna trials.
• Lead review of biomarker sections in protocols, lab manuals and consent forms.
• Finalize central lab database specs including sample kit development, storage, shipping, testing and reporting.
• Track and manage clinical sample lifecycle from collection to long-term storage.
• Monitor sample quality issues and drive resolutions.
• Ensure biosample use complies with informed consent and GCP/ICH.

Skills

Clinical research

Biomarker sample management

Excel

GCP/ICH knowledge

Communication skills

Multitasking

Education

Bachelor's degree in life sciences

Tools

Excel

LIMS (Laboratory information management system)

Job description

The Role

Moderna is seeking a Biomarker Operations Manager to support biomarker and clinical teams 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 for implementation of clinical biomarker sample management plans and deliverables in Moderna clinical trials
• Lead the review of biomarker sections of clinical protocols, lab manuals and consent forms
• Lead central lab database specification finalization, including clinical sample kit development, sample storage, sample shipment, sample testing and reporting.
• Track and manage clinical sample lifecycle processes from sample collection to long term storage
• Monitor clinical sample quality issues and implement issue resolutions
• Support clinical teams to ensure biosample usage is compliant with informed consent and GCP/ICH requirements.
• Participate in clinical assay vendor oversight, by attending meetings, addressing sample issues, and requesting sample shipments
• Promote process improvements for clinical sample lifecycle
• Lead the development of processes and procedures for standardized language, biomarker usage, and data reporting

Here’s What You’ll Need (Basic Qualifications)

• 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
• Familiarity with Excel is essential
• Solid understanding of GCP/ICH is required
• Strong communication skills and attention to detail
• Demonstrated ability to multitask

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 $109,200.00 - $174,600.00. 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.

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.

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.

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

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 Notice This 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.