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.

• 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.
• Prioritize initiatives based on business value, patient impact, regulatory requirements, and scientific needs.

• 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.
• 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.

• 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.

• Lead collaboration across 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.

• 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.

• 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.

• Author and oversee high‑quality documentation.
• Lead validation activities.
• Ensure audit‑ready documentation and full traceability across system lifecycle.

• 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 owning complex systems such as LIMS and lab instrument platforms.
• Proven ability to define strategy and deliver solutions in regulated environments.

• Experience in clinical biomarker laboratories and assay workflows.
• Hands‑on experience with Lab Vantage, 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…