Bioanalysis and Biomarker Outsourcing Manager
Core
Oversee outsourced bioanalytical and biomarker activities across preclinical and clinical study stages, ensuring high-quality data delivery and operational excellence.
Role type
Senior manager of outsourced bioanalysis and biomarker operations
Builds
High-quality bioanalytical and biomarker data for drug development programs
Domain
Biopharma, preclinical and clinical drug development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Vendor management, budget forecasting, GxP compliance, assay validation oversight, regulatory inspection support, contract negotiation, cross-functional collaboration
Preferred skills
Experience in regulated bioanalysis, clinical biomarker development, translational medicine, managing external CROs
Technologies
None explicitly stated
Responsibilities
Partner with biomarker teams to execute strategies; manage vendor onboarding and performance; oversee PK and ADA bioanalytical activities; support audit preparations and regulatory submissions; manage study budgets and timelines
Seniority
Senior, hands-on IC with management responsibilities
