Role Summary
The Associate Director, Precision Diagnostics Development is accountable for ensuring that companion diagnostic testing or equivalent segmentation tools are operationalized in clinical studies. The role implements the diagnostic strategy approved with drug product teams and collaborates across the Precision Medicine and Biosamples function to deliver testing expertise to drug project teams. The role may lead or contribute to diagnostic delivery within a sub-team and is accountable for aligning activities with the AstraZeneca Code of Conduct and supporting policies.
Responsibilities
- Implement appropriate diagnostic testing strategies within the product teams to meet the needs of patients, payers, physicians and contribute to drug products
- Obtain and handle investment to enable companion diagnostic development for the relevant product teams
- Deliver expert advice of high scientific quality on testing options for precision medicine approaches and companion diagnostic development to relevant product teams
- Provide leadership within PMB, including communication of a clear testing strategy and inspirational vision.
- As project manager of diagnostic delivery, contribute to the performance management and personal development of project team members
- Monitor and ensure compliance with all AstraZeneca Policies and Standards and immediately address instances of non-compliance.
- Implement delivery of diagnostic tests for use in clinical trials, regulatory submission and commercialisation
- Draw upon previous experience and expert knowledge to provide a relevant knowledge base of companion diagnostic development and competitive intelligence for product teams
- Ensure delivery of objectives and turning points for diagnostic delivery to product teams with the Heads of CDU/PMU and relevant product leaders
- Accountable for the delivery of diagnostic plans to time, budget and quality.
- Provide regular updates on all PMB activities for the relevant product teams for progress, risks, issues and opportunities to governance bodies or CDU/PMU Head as required
- Work with functional representatives to resolve resource, quality and budget issues
- Manage risk in an appropriate and compliant manner
- Governance processes and partner interactions