Diagnostic Science Manager

at  AstraZeneca

THE ROLE HOLDER WILL BE ACCOUNTABLE FOR

• delivery of work packages involving the development of diagnostics as agreed with project leaders
• developing innovative diagnostics science across core therapeutic areas
• scientific and regulatory aspects of diagnostic test establishment in testing laboratories, including delivery and quality control of clinical data packages to enable regulatory approvals to support market adoption and life cycle management.
• ensuring that all activities are delivered demonstrating behaviours and values aligned to AstraZeneca Code of Conduct and supporting policies, standards and procedures, including compliant management of Budget, Safety, Health and Environment.

TYPICAL ACCOUNTABILITIES, WHAT YOU WILL BE DOING:

• Lead innovative diagnostic science to fulfil Precision Medicine approaches and deliver diagnostic testing to clinical studies as agreed with project leaders including:
• Technical and scientific input into the diagnostic strategy
• Technical due diligence on diagnostic partner options
• Delivery of technical evaluation of assays/test labs
• Lead diagnostic test establishment in partner laboratories
• QC and Monitor diagnostic test data throughout duration of clinical trial
• Provide scientific troubleshooting when necessary
• Preparation of study reports with presentation at appropriate meetings.
• Lead the delivery of diagnostic data work packages to enable regulatory submission and approval as well as identifying opportunities to remove barriers to real-world diagnostic testing.
• Build and maintain a knowledge of current and emerging diagnostic assay technologies in area of expertise.
• Drive continuous improvement in the scientific area(s) of expertise, aligned to Precision Medicine strategic objectives of increasing project success, adding value to projects and delivering better medicines to patients.
• Be accountable for the time, cost and quality of agreed deliverables.
• Provide updates on the progress, risks and opportunities of the agreed deliverables to the appropriate governance bodies for review, challenge and issue resolution.
• Takes on small supervisory or skills transfer / training roles
• Monitor and ensure compliance with all AstraZeneca Policies and Standards, and local law/regulation, and immediately address instances of non-compliance.