As anAssociate Director,Molecular 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 withproject leaders

• The development of innovative diagnostics science across core therapeutic areas and disciplines

• Scientific and regulatory aspects of diagnostic test establishment in testinglaboratories, quality control for the delivery to clinical studies anddelivery 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.

• 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 labelling.

• 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:

• Masters / PhD or equivalent experience in a relevant subject

• Record of delivery in a diagnostics capability

• Leadership ability and global team working

• Excellent molecular biology skills including experience in Next-Generation Sequencing (NGS), qPCR and/or dPCR, DNA and RNA handling methodsand other relevant molecular biology and/or genomics technique

• 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 external boundaries.

• Ability to communicate with cross-functional stakeholders for project updates through oral presentations and progress reports

• Ability to identify risks and escalate appropriately

• Good interpersonal skills and ability to act as an ambassador for Precision Medicine internally and externally

• Can work in multidisciplinary teams/projects and can influence across disciplines

• Ability to manage change and uncertainty

• A confident team player who is assertive but willing to listen and learn from the views of others

• Excellent organisational skills, with the proven ability to deliver high quality work under pressure and against tight timelines

• Knowledge of, and enthusiasm for, the aims and objectives of personalised healthcare

• Willingness to travel both nationally and internationally

Desirable:

• Line management experience

• Excellence in the recruitment, retention, development and motivation of groups of highly qualified scientists

• 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

• Good computational analysis skills enabling automated/semi-automated data analysis (e.g. using programmes such as R, Pyton, knime or equivalent)

• Knowledge of requirements related to handling of Human Biological Samples

• Experience in computational approaches to data analysis and handling large data sets

Location:Cambridge, UK; Warsaw, Poland; Barcelona, Spain

Salary: Competitive + Excellent Benefits

Next steps, if you feel you are suitable for the role please apply!