Sr. Product Manager, Clinical Biomarker Systems

Overview

Senior Product Manager, Clinical Biomarker Systems – define and lead strategy, development, and lifecycle management of digital platforms supporting clinical biomarker laboratories at Moderna.

• Define and own 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; maintain validated state and adhere to ALCOA+ data integrity principles.
• Support inspection readiness activities, including FDA and global regulatory audits; 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 from requirements definition to deployment and continuous improvement.
• Lead cross-functional collaboration with clinical biomarker labs, digital & engineering teams, quality & validation, and clinical development teams; influence senior stakeholders across multiple functions.
• Oversee CROs, external laboratories, and system vendors to ensure compliance with quality and regulatory standards.
• Define and monitor KPIs for system performance, data quality, and operational efficiency; leverage biomarker data to drive insights, optimize workflows, and accelerate clinical decision-making.
• Author high-quality documentation (URS, functional & design specifications, SOPs, work instructions); lead validation activities (risk assessments, test strategy, UAT) and ensure audit-ready documentation.

• 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.

• 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 as JIRA, Kneat, Service Now.
• Demonstrated ability to translate scientific and regulatory requirements into scalable digital products.

• Competitive compensation with salary range of $ – $ and potential bonus, incentive, or equity.
• Comprehensive healthcare and voluntary benefit programs.
• Well‑being resources including fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Generous paid time off (vacation, volunteer days, sabbatical, global recharge days, discretionary year‑end shutdown).
• Savings and investment plans.
• Location‑specific perks and extras.

Moderna is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to 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 protected characteristic. If you meet the Basic Qualifications and are excited to contribute to our mission, we invite you to apply.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Contact Accommodations at leavesan for assistance.

Only U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. This role may involve access to technology or data subject to U.S. export control laws.