Manager, Biomarker Operations

Initial Therapeutics, Inc.; Cambridge (MA); On-site; USD 109,200 - 174,600; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Fertility/adoption/surrogacy support

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna in Cambridge, MA 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.

You will lead the development and execution of biomarker sample management plans, review biomarker sections of protocols, manage the clinical sample lifecycle, ensure GCP/ICH compliance, and drive process improvements across the biomarker program.

Qualifications

• Bachelor’s degree required in a life science field; advanced degree preferred.
• 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.

Responsibilities

• 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.

Skills

Communication skills

Attention to detail

Multitasking

GCP/ICH knowledge

Education

Bachelor’s degree in life sciences

Tools

Excel

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.

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. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

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.