Senior Dx Scientist, Tissue Dx

Typical Accountabilities:

• 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

• Bachelor / Masters / PhD or equivalent experience in a relevant subject
• Fluent English communication and presentation.
• Demonstrable experience of analytical diagnostic assay validation and the use in a clinical testing setting.
• Ability to communicate with stakeholders for study updates, testing progress through oral presentations and progress reports
• Knowledge of clinical trial sample biomarker testing procedures, and applicable laboratory testing regulations and quality systems (eg, GCP, CAP, CLIA, etc)
• Proven experience of delivery and use of data for diagnostic projects - 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.
• Experience of working within a global team.
• Knowledge in Tissue diagnostic technologies (IHC, FISH, Dual-ISH, etc.)

Skills & Capabilities

• Good interpersonal skills and ability to act as an ambassador for Precision Medicine internally and externally
• Capability of fluently English communication and writing
• Ability to interact successfully with multiple customers across functional boundaries
• Ability to work independently, designing, executing and interpreting tasks
• Can identify and address critical issues in the context of strategic direction
• A confident team player who is assertive but willing to listen and learn from the views of others
• Ability to influence within own discipline and apply constructive challenge
• 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

• Pharmaceutics or diagnostic company working experience for clinical trials, and also CRO lab management experience are highly desired.
• Experience of leading projects within a diagnostic or drug development organization.
• An understanding of drug and companion diagnostic assay co-development, partnering, commercialization and experience working in early and late phase projects
• Knowledge of scientific literature with deep understanding in diagnostic related area demonstrated through publications in peer reviewed journals.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.