Note: The job is a remote job and is open to candidates in USA. Moderna is a biotechnology company focused on advancing mRNA medicines through innovative science and technology. The Senior Product Manager for Clinical Biomarker Systems will lead the strategy and development of digital platforms for clinical biomarker laboratories, ensuring compliance and data integrity to support clinical trials and regulatory submissions.
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
- Prioritizing 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 (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
- 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
Skills
- 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)
- 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 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
- 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
- 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
Company Overview