Associate Director, Precision Diagnostics Development – Early Oncology

AstraZeneca • Gaithersburg, MD

2d • Hybrid

About The Position

The Associate Director, Precision Diagnostics Development – Early Oncology is accountable for ensuring that the companion diagnostic testing or equivalent segmentation tools are operationalized in our pivotal 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 Precision Diagnostics Development Early Oncology team. Each Associate Director will be accountable for project leading delivery to the pivotal clinical study (and other associated clinical studies). The role holder will also be accountable for running the Diagnostic Development sub-team on behalf of the drug project team. 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 Diagnostics Development (PDD) function to deliver this expertise to drug project teams. As a PDD 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. Typical Accountabilities: Strategic direction Implement appropriate diagnostic testing strategies within the product team(s) to meet the needs of patients, payers, physicians and contribute to drug products Acquire and handle investment to enable companion diagnostic development for the relevant product teams Deliver authoritative advice of high scientific quality on testing options for precision medicine approaches and companion diagnostic development to relevant product teams Identify the efficient diagnostic partner and collaborate closely to co-develop the diagnostic Leadership: Provide leadership within PDD, including communication of a clear diagnostic strategy and inspirational vision. As the Lead for the diagnostic delivery, contribute to the performance management and personal development of project team members Supervise 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, in readiness for regulatory submission and commercialisation Draw upon previous experience and authority knowledge to provide a relevant knowledge base of companion diagnostic development and competitive intelligence for product teams Planning, Monitoring and Delivering Ensure delivery of objectives and turning points for diagnostic delivery to product teams with the leader of PDD and relevant drug product leaders Accountable for the delivery of diagnostic plans to time, budget and quality. Assessing and Leading Risk Provide regular updates on all PDD activities for the relevant product teams for progress, risks, issues and opportunities to governance bodies or PDD leadership as required Work with functional representatives to resolve resource, quality and budget issues Lead risk in an appropriate and compliant manner

Requirements

• Bachelor’s with 8 years or Master’s Degree and 5 years of proven experience
• Experience in companion diagnostic tests or segmentation tools in clinical development OR Experience of precision medicine approaches and diagnostic development within the relevant therapeutic area
• Evidence of effective skills in communication, stakeholder influencing, programme management.
• Understanding of the functions involved in companion diagnostic development and how they contribute to achieving the objectives of the business

Nice To Haves

• PhD preferred
• Previous experience in similar role in different companies
• Delivery of clinical testing, diagnostics, regulatory preparation
• Scientific expertise in the precision medicine field or relevant therapeutic area as evidenced by publications

Responsibilities

• Implement appropriate diagnostic testing strategies within the product team(s) to meet the needs of patients, payers, physicians and contribute to drug products
• Acquire and handle investment to enable companion diagnostic development for the relevant product teams
• Deliver authoritative advice of high scientific quality on testing options for precision medicine approaches and companion diagnostic development to relevant product teams
• Identify the efficient diagnostic partner and collaborate closely to co-develop the diagnostic
• Provide leadership within PDD, including communication of a clear diagnostic strategy and inspirational vision.
• As the Lead for the diagnostic delivery, contribute to the performance management and personal development of project team members
• Supervise 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, in readiness for regulatory submission and commercialisation
• Draw upon previous experience and authority 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 leader of PDD and relevant drug product leaders
• Accountable for the delivery of diagnostic plans to time, budget and quality.
• Provide regular updates on all PDD activities for the relevant product teams for progress, risks, issues and opportunities to governance bodies or PDD leadership as required
• Work with functional representatives to resolve resource, quality and budget issues
• Lead risk in an appropriate and compliant manner

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Director