Outsourcing Manager

Job Description

Responsibilities:

• Act as the project manager to support the externalization and operationalization of clinical biomarkers and bioanalytical activities for pre-clinical and clinical drug development.
• Support the team on budget predictions, management and tracking for a clear understanding of the biomarker operations and their impact on the project.
• Be the key point of contact for biomarker activities whether they are managed externally or internally to inform the team to make data driven decisions.
• Oversee PK or ADA bioanalysis that is performed externally.
• Identify and help onboard vendors for specific analysis, provide advice and support on scientific and technical aspects of analysis where possible.
• Interact closely with Translational Medicine (TM) sub teams to execute biomarker plans for clinical studies.
• Monitor assay development, assay validation and sample analysis processes, ensure timely delivery of quality results in compliance with regulation