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.

Heres What Youll 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.

Heres What Youll Need (Basic Qualifications)

• Bachelors degree in Science Biotechnology Engineering Computer Science or related field

• 610 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

Heres What Youll Bring to the Table (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

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work at home and everywhere in between.

• Best-in-class healthcare coverage 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 investment opportunities to help you plan for the future

• Location-specific perks and extras

About Moderna

Since our founding in 2010 we have aspired to build the leading mRNA technology platform the infrastructure to reimagine how medicines are created and delivered and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission values and mindsets every day our people are the driving force behind our scientific progress and our culture. Together we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.

Our Working Model

As we build our company we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.

Moderna is a smoke-free alcohol-free and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons 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 is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Accommodations

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.

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 .

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