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Norwood, Massachusetts, United States
Onsite
The Role
Joining Moderna offers the opportunity to be part of a transformative team advancing mRNA medicines through cutting-edge science and digital innovation. As a Senior Product Manager, Clinical Biomarker Systems, you will define and lead the strategy, development, and lifecycle management of digital platforms supporting clinical biomarker laboratories. This role operates at the intersection of clinical science, digital technology, and regulated environments, ensuring biomarker data is reliable, compliant, and scalable to support clinical development and regulatory submissions. You will own complex product ecosystems spanning LIMS, laboratory instruments, and data integrations, enabling high-quality biomarker data generation aligned with GxP, GLP, and GCP requirements. Your work will directly impact clinical trial execution, regulatory readiness, and the delivery of innovative therapies to patients.
Here's What You’ll Do
Product Strategy & Ownership:
Define and own the product vision, strategy, and roadmap for Clinical Biomarker Systems across LIMS, instrument platforms, and data pipelines.
Drive development of scalable, compliant, and user-centered digital solutions that support biomarker workflows and clinical trial execution.
Prioritizing initiatives based on business value, patient impact, regulatory requirements, and scientific needs.
Regulatory Compliance & Data Integrity (Moderna Quality Standard):
Ensure all systems comply with GxP (GLP, GCP), 21 CFR Part 11, and EU Annex 11 requirements.
Maintain systems in a validated state, ensuring adherence to ALCOA+ data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Ensure biomarker data is fit-for-purpose for clinical endpoints and regulatory submissions.
Support and lead inspection readiness activities, including FDA and global regulatory audits.
Partner with Quality to manage change control, deviations, CAPAs, and periodic reviews for all regulated systems.
System Ownership & Lifecycle Management
Act as system owner for Clinical Biomarker platforms (e.g., LIMS, instrument systems).
Oversee full lifecycle:
Requirements definition, Design and configuration, Validation (CSV), Deployment and continuous improvement
Ensure systems remain compliant, scalable, and aligned with evolving regulatory and business needs.
Cross-functional Leadership (C8 Scope)
Lead collaboration across:
Clinical biomarker labs
Digital & engineering
Quality & validation
Clinical development teams
Influence decision-making across multiple functions and engage senior stakeholders.
Drive alignment between scientific, operational, and digital teams to deliver integrated solutions.
Vendor & External Partner Oversight
Oversee CROs, external laboratories, and system vendors to ensure compliance with Moderna quality and regulatory standards.
Ensure third-party systems and processes meet GxP and data integrity expectations.
Business Impact & Data Utilization
Define and monitor KPIs for system performance, data quality, and operational efficiency.
Leverage biomarker and operational data to drive insights, optimize workflows, and accelerate clinical decision-making.
Conduct advanced analysis to quantify impact and ROI of digital initiatives.
Documentation & Validation Excellence
Author and oversee high-quality documentation:
User Requirements (URS)
Functional & Design Specifications
SOPs and Work Instructions
Lead validation activities:
Risk assessments
Test strategy and execution
User Acceptance Testing (UAT)
Ensure audit-ready documentation and full traceability across system lifecycle.
Here’s What You’ll Need (Basic Qualifications)
Bachelor’s degree in Science, Biotechnology, Engineering, Computer Science, or related field
6–10+ years of experience in product management, lab informatics, or digital systems in biotech/pharma
Strong expertise in:
GxP (GLP/GCP) environments
Clinical trial data workflows
Data integrity and validation (CSV)
Experience owning complex systems such as LIMS and lab instrument platforms
Proven ability to define strategy and deliver solutions in regulated environments
Here’s What You’ll Bring to the Table (Preferred Qualifications)
Experience in clinical biomarker laboratories and assay workflows
Hands-on experience with LabVantage, Watson, or similar LIMS platforms
Experience supporting regulatory inspections and audits (FDA, EMA)
Familiarity with clinical data standards (CDISC, SDTM)
Experience working with CROs and external lab vendors
Strong business acumen with ability to define KPIs and measure impact
Experience with tools such as JIRA, Kneat, ServiceNow
Demonstrated ability to translate scientific and regulatory requirements into scalable digital products
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.
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.
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 leavesandaccommodations@modernatx.com.
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.
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