Associate Director, Translational Biomarkers and Bioanalytics

Tasks

• Coordinate matrix team deliverables
• Design and deliver bioanalytical work
• Develop biomarker strategy
• Draft responses to health authority questions
• Ensure documentation and data integrity
• Implement biomarker assay validation
• Lead bioanalytical strategy
• Lead immunogenicity risk assessment
• Manage compliant sample collection and chain of custody
• Oversee bioanalytical vendors
• Provide input to clinical and regulatory documents
• Represent team on cross functional projects
• Review bioanalytical and biomarker results
• Support regulatory submissions
• Support study start up and database lock

Perks/Benefits

• Hybrid work

Skills/Tech-stack

Assay validation | Bioanalytical Chemistry | Biomarker Assay | Cell-based assays | Chain of Custody | Clinical trial | Corrective and Preventive Action | Data Integrity | Drug Metabolism | Flow Cytometry | Genomics | Immunoassay | Immunogenicity | Liquid Chromatography | Liquid chromatography tandem mass spectrometry | Mass Spectrometry | Method validation | Pharmaceutical Sciences | Pharmacology | Preventive Action | Quality Assurance | Regulatory Compliance | Regulatory Submissions | Tandem Mass Spectrometry | Toxicology | Vendor management