Associate Director, Biopharm Diagnostics

2 weeks ago

Cambridge, United Kingdom AstraZeneca Full time

Precision Medicine and BioSamples within AstraZeneca focuses on matching medicines to those patients who will benefit from them most and delivers companion or complementary diagnostic assays that align with the drug development process and enable personalised healthcare approaches within our clinical portfolio.

As an Associate Director, you will join the **Biopharm Diagnostics team. **You will drive diagnostic development across a wide range of chronic disease areas and diagnostic technologies.

You will provide scientific, technical, regulatory diagnostic expertise and data to drug project teams following a Precision Medicine approach. Specifically, you’ll be accountable for
- leading the delivery of significant work packages of analytical diagnostic validation as agreed with Precision Medicine project representatives. This will include working in collaboration with internal and external partners to design scientific experiments and technical refinements to convert exploratory biomarkers into clinical decision-making diagnostic devices.
- 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**:

- 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.
- Contribute to the overall performance of the Diagnostic Development group of the Precision Medicine function, driving efficiency and infrastructure improvements.
- 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
- Hands-on experience of developing enzyme linked immunoassays (ELISA), including use of regulatory approved platforms
- Expertise in LC-Mass-Spectrometry method validation, including measurement of large and small molecules
- 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 external boundaries.

**Desirable**:

- An understanding of drug and companion diagnostic assay co-development and commercialisation and experience working in early and late phase projects
- Demonstrable experience of analytical diagnostic assay validation and use in a clinical testing setting
- Proven experience of delivery and use of data for diagnostic projects for regulatory submissions
- Knowledge of requirements related to handling of Human Biological Samples

**Locations**
- Cambridge, UK (primary)

**Salary**:Competitive + Excellent

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