Moderna
Sr. Product Manager, Clinical Biomarker Systems
Norwood, Massachusetts, USA · Senior · Contract
No sponsorship$146k-$234kDetected 15 days ago
GCPComplianceProduct ManagementProduct StrategyJiraFDA RegulatoryLeadershipCollaborationGxP
About the role
- Joining Moderna offers the opportunity to be part of a transformative team advancing mRNA medicines through cutting-edge science and digital innovation.
- Your work will directly impact clinical trial execution, regulatory readiness, and the delivery of innovative therapies to patients.
- Regulatory Compliance & Data Integrity (Moderna Quality Standard):
Responsibilities
- 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.
- Maintain systems in a validated state, ensuring adherence to ALCOA+ data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
- 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.
- Requirements definition, Design and configuration, Validation (CSV), Deployment and continuous improvement
- Drive development of scalable, compliant, and user-centered digital solutions that support biomarker workflows and clinical trial execution.
- Proven ability to define strategy and deliver solutions in regulated environments
Requirements
- 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
- Hands-on experience with LabVantage, Watson, or similar LIMS platforms
Compensation
- The salary range for this role is $145,900.00 - $234,200.00.
Benefits
- Define and own the product vision, strategy, and roadmap for Clinical Biomarker Systems across LIMS, instrument platforms, and data pipelines.
Visa & Work Authorization
- thout 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, sexua
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