Sr. Product Manager, Clinical Biomarker Systems

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)