Associate Director, Precision Diagnostics Development

AstraZeneca•Gaithersburg, MD

37d

About The Position

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 holder will achieve this by implementing the diagnostic strategy agreed with drug product teams. The role holder will be a member of a Companion Diagnostic Unit (CDU) (or Precision Medicine Unit PMU) that is aligned to the relevant therapeutic area; the role holder will also support other therapeutic areas as required. Each Associate Director will be accountable for project leading delivery to several clinical studies. The role holder may be accountable for specific aspects of a Diagnostic Development sub-team run by senior Diagnostic Experts. The role holder will be accountable to the Leaders of the relevant product teams for ensuring that diagnostic development reflects extraordinary practice in the field and contributes to increased probability of successful drug launch, reimbursement and return on investment. The Associate Director works collaboratively with colleagues as all levels in the Precision Medicine and Biosamples (PMB) function to deliver this expertise to drug project teams. As a PMB leader, the role holder is accountable for ensuring that all activities are delivered demonstrating behaviours and values aligned to AstraZeneca Code of Conduct and supporting policies, standards and procedures; including accountability for compliant management of Budget, Safety, Health and Environment.

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