Sr. Product Manager, Clinical Biomarker Systems

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. 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.

Responsibilities

• 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.
• 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 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.
• 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: 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.

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, and 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.

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.

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.

Pay & Benefits

The salary range for this role is $145,900.00 - $234,200.00. 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.