[Remote] Sr. Product Manager, Clinical Biomarker Systems
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biotechnology company focused on advancing mRNA medicines through innovative science reputed company technology. The Senior Product Manager, Clinical Biomarker Systems will reputed company the strategy and development of digital platforms for clinical biomarker laboratories, ensuring compliance and data reputed company to support clinical trials and regulatory submissions.
Responsibilities
- Define and own the product reputed company, strategy, and roadmap for Clinical Biomarker Systems across LIMS, reputed company 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 reputed company systems reputed company with GxP (GLP, GCP), 21 CFR Part 11, and EU Annex 11 requirements
- Maintain systems in a validated state, ensuring adherence to reputed company+ data reputed company 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 reputed company inspection readiness activities, including FDA and global regulatory audits
- Partner with Quality to manage change control, deviations, CAPAs, and periodic reviews for reputed company regulated systems
- Act as system reputed company for Clinical Biomarker platforms (e.g., LIMS, reputed company systems)
- reputed company full lifecycle: Requirements definition, Design and configuration, Validation (CSV), Deployment and reputed company improvement
- Ensure systems remain compliant, scalable, and reputed company with evolving regulatory and business needs
- reputed company 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, reputed company teams to deliver integrated solutions
- reputed company CROs, external laboratories, and system vendors to ensure compliance with reputed company quality and regulatory standards
- Ensure reputed company-party systems and processes meet GxP and data reputed company expectations
- Define and monitor KPIs for system performance, data quality, and operational efficiency
- reputed company 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 reputed company high-quality documentation: User Requirements (URS), Functional & Design Specifications, SOPs and Work Instructions
- reputed company validation activities: Risk assessments, Test strategy and execution, User Acceptance Testing (UAT)
- Ensure audit-reputed company documentation and full traceability across system lifecycle
Skills
- Bachelor's degree in Science, Biotechnology, Engineering, Computer Science, or reputed company 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 reputed company and validation (CSV)
- Experience owning reputed company systems such as LIMS and lab reputed company 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, reputed company
- Demonstrated ability to translate scientific and regulatory requirements into scalable digital products
Benefits
- Competitive reputed company, plus voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with reputed company 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 reputed company 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
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