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Associate Director, Tissue Diagnostics

4 months ago

Cambridge, United Kingdom AstraZeneca Full time

**_Associate Director, Tissue Diagnostics_**

AstraZeneca delivers companion or complementary diagnostic assays that match medicines to those patients who are most likely to benefit from them. This approach, known as **Precision Medicine**, is based on those individual characteristics that make some patients respond to treatment better than others. We use this knowledge to develop diagnostic tests that doctors can use to help prescribe the best treatment for each patient.

As an **Associate Director,** **Tissue Diagnostics**, you will provide **scientific** and **regulatory diagnostic** expertise and delivery to drug project teams following a diagnostics approach.

**The role holder will be accountable for**:

- The delivery of work packages involving the development of diagnostics as agreed with project leaders
- The development of innovative diagnostics science across core therapeutic areas and disciplines
- Scientific and regulatory aspects of diagnostic test establishment in testing laboratories, quality control for the delivery to clinical studies and delivery of data packages to enable regulatory approvals including studies 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**:

- Oversee the delivery of diagnostic testing across franchises or a wider portfolio of projects, through direct or indirect coordination of Diagnostic Development team members
- Significant supervisory, team leader or group leader accountability often as formal line manager. Attract, recruit, and retain top talent and technical expertise. Lead performance management and personal development of group members through coaching, mentoring, and motivating. Ensures delivery of team objectives in line with business objectives.
- Contribute to the overall performance of the Diagnostic Development group of the Precision Medicine function as a senior team member, driving efficiency and infrastructure improvements.
- Lead the delivery of complex diagnostic data work packages to enable regulatory submission and approval inclusive of studies to enable market adoption and life cycle management.
- 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, diagnostic test establishment in partner laboratories, monitor diagnostic test data for quality control, provide scientific troubleshooting when necessary and preparation of study reports with presentation at appropriate meetings.
- Leading internal lab based activities to deliver project requirements
- 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.
- Monitor and ensure compliance with all AstraZeneca Policies and Standards, and local law/regulation, and immediately address instances of non-compliance.

**Education, Qualifications, Skills and Experience**:
**Essential**:

- Record of delivery in a diagnostics capability
- Leadership ability and global team working
- Excellent tissue-based assay skills including experience in immuno-histochemistry (IHC), in situ hybridisation (ISH) and other relevant techniques
- Excellent knowledge of scientific literature with deep understanding in molecular biology and/or diagnostic related area demonstrated through publications in peer reviewed journals
- Experience of leading projects within a diagnostic or drug development organisation
- Demonstrable experience of analytical diagnostic assay validation and use in a clinical testing setting
- Knowledge of clinical testing procedures and applicable laboratory testing regulations such as Good Clinical Practice, CAP/CLIA, ISO and Quality Systems Regulation
- Proven experience of delivery and use of data for diagnostic development for regulatory submissions, including proven experience of quality control and data monitoring and troubleshooting
- Experience of working with external partners or collaborators (ideally diagnostic companies) to drive timely and successful outcomes, through effectively working across internal and ext