Sr. Product Manager, Clinical Biomarker Systems
Core
Define and lead the strategy, development, and lifecycle management of digital platforms supporting clinical biomarker laboratories to ensure reliable, compliant, and scalable data for clinical development and regulatory submissions.
Role type
Senior Product Manager, Clinical Biomarker Systems
Builds
Digital platforms for clinical biomarker labs, LIMS, laboratory instruments, and data pipelines
Domain
Biotechnology / Clinical Trials / Regulated Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Product strategy and roadmap ownership, GxP (GLP/GCP) compliance, Data integrity (ALCOA+), System lifecycle management (CSV), Cross-functional leadership, Vendor/CRO oversight, KPI definition and data analysis, Regulatory documentation and validation (URS, SOPs, UAT)
Preferred skills
Clinical biomarker lab and assay workflow experience, LIMS platform expertise (LabVantage, Watson), Regulatory inspection support (FDA/EMA), Clinical data standards (CDISC, SDTM), CRO/vendor management, Business acumen, Project management tools (JIRA, ServiceNow)
Technologies
LIMS, LabVantage, Watson, JIRA, ServiceNow, Kneat
Responsibilities
Define product vision and roadmap for biomarker systems; Ensure system compliance with GxP, 21 CFR Part 11, and EU Annex 11; Oversee full system lifecycle from requirements to validation and deployment; Lead cross-functional collaboration with clinical, digital, and quality teams; Manage vendor and CRO relationships; Define and monitor KPIs for system performance and data quality; Author validation documentation and lead testing activities.
Seniority
Senior, hands-on IC