R-290721 Associate Director Clinical Assay Strategy
Core
Lead external tactical execution and strategy for bioanalytical and biomarker assays to support nonclinical and clinical studies, ensuring delivery of innovative assays and key data sets.
Role type
Associate Director, Clinical Assay Strategy
Builds
Bioanalytical and biomarker assays for clinical programs
Domain
Life Sciences / Biotherapeutics / Clinical Bioanalysis
Required skills
Bioanalytical assay design and validation, Biomarker assay development, Regulatory compliance (FDA/EMA), Vendor management, Cross-functional leadership, Risk management, Data interpretation, Strategic planning
Preferred skills
AI in regulated environments, Automated workflows, Advanced assay platforms
Technologies
Bioanalytical platforms, Biomarker formats, Automated workflows
Responsibilities
Develop and implement bioanalytical/biomarker strategies, Lead external due diligence and vendor selection, Manage technical transfer of assays to external vendors, Provide scientific guidance on complex data and regulatory submissions, Optimize workflows for turn-around times and resource allocation, Represent the organization at scientific conferences
Seniority
Senior, hands-on IC with leadership