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
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