Sr. Product Manager, Clinical Biomarker Systems

Overview 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) 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 Pay & 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. The salary range for this role is $145,900.00 – $234,200.00. Equal Opportunities Moderna is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person's 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 personal characteristic protected under applicable law. E‑Verify Employer Moderna is an E‑Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at View email address on click.appcast.io. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export‑controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non‑U.S. persons to apply for an export control license. #J-18808-Ljbffr Moderna Therapeutics