At AstraZeneca every one of our employees makes a difference to patient lives everyday.
Precision Medicine 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.
The role holder will provide scientific and regulatory diagnostic expertise and delivery to drug project teams following a diagnostics approach. Specifically, the role holder will be 1. Accountable for the delivery of work packages involving the development of diagnostics as agreed with project leaders. 2. Accountable for developing innovative diagnostics science across core therapeutic areas and disciplines. 3. Accountable for 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. 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 compliant management of Budget, Safety, Health and Environment.
Typical Accountabilities, what you will be doing:
- Lead innovative diagnostic science to fulfil Precision Medicine approaches.
- Lead the delivery of diagnostic testing to clinical studies as agreed with project leaders including: 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.
- Lead the delivery of diagnostic data work packages to enable regulatory submission and approval inclusive of studies to enable market adoption and life cycle management.
- Manage projects across internal and external partners in a global multi-disciplinary environment, applying scientific, technical and operational expertise. Identify opportunities, propose solutions and work across boundaries in the scientific area(s) of expertise that will enable drug development projects and diagnostics labeling.
- 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.
- Takes on small supervisory or skills transfer / training roles
- 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:
- Masters / PhD or equivalent experience in a relevant subject
- Demonstrable experience of analytical diagnostic assay validation and use in a clinical testing setting.
- Excellent knowledge of scientific literature with deep understanding in diagnostic related area demonstrated through publications in peer reviewed journals.
- Knowledge of clinical testing procedures and applicable laboratory testing regulations such as Good Clinical Practice, CAP/CLIA, Good Clinical Practice and Quality Systems Regulation)
- Proven experience of delivery and use of data for diagnostic projects for regulatory submissions - including quality control, test data monitoring and troubleshooting
- Experience of working with diagnostic partners to drive timely and successful outcomes, through effectively working across internal and external boundaries.
- Ability to communicate with stakeholders for study updates, testing progress through oral presentations and progress reports
- Ability to identify risks and escalate appropriately
- An understanding of drug and companion diagnostic assay co-development and commercialisation and experience working in early and late phase projects
- Experience of leading projects within a diagnostic or drug development organisation.
- Understanding of related areas e.g. segmentation tool discovery, drug-diagnostic co-development, partnering and commercialisation.
Role is a 12 month fixed-term contract or secondment.
Closing Date: 20th September 2020
Next steps, if you feel you are suitable for the role please apply!