Associate Principal Scientist, Tissue Dx

Typical Accountabilities:

• Oversee the delivery of diagnostic testing across franchises or a wider portfolio of projects, through direct or indirect coordination of Diagnostic Development staff
• 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.
• 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.
• 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.
• Monitor and ensure compliance with all AstraZeneca Policies and Standards, and local law/regulation, and immediately address instances of non-compliance.

Qualifications:

• Masters / PhD or equivalent experience in a relevant scientific subject, with > 6 years industry working experience in areas of biomedicine research & development.
• Fluent English communication and presentation.
• Leadership ability, global team working experience.
• Record of delivery in a diagnostics capability..Experience of leading projects within a diagnostic or drug development organization.
• Demonstrable experience of analytical diagnostic assay development, validation and the use in a clinical testing setting
• Good knowledge of clinical trial sample biomarker testing procedures, and applicable laboratory testing regulations and quality systems (eg, GCP, CAP, CLIA, etc)
• Proven rich experience of delivery and use of data for diagnostic projects - including quality control, test data monitoring and troubleshooting
• Intensive experience of working with diagnostic partners to drive timely and successful outcomes, through effectively working across internal and external boundaries.
• Pharmaceutics or diagnostic company working experience for clinical trials, and also CRO lab management experience
• Excellent knowledge in Tissue diagnostic technologies (IHC, FISH, Dual-ISH, etc.) and also scientific literature with deep understanding in diagnostic related area demonstrated through publications in peer reviewed journals.
• Experience in healthy authority Inspection
• Masters / PhD or equivalent experience in a relevant scientific subject, with > 6 years industry working experience in areas of biomedicine research & development.
• Fluent English communication and presentation.
• Leadership ability, global team working experience.
• Record of delivery in a diagnostics capability..Experience of leading projects within a diagnostic or drug development organization.
• Demonstrable experience of analytical diagnostic assay development, validation and the use in a clinical testing setting
• Good knowledge of clinical trial sample biomarker testing procedures, and applicable laboratory testing regulations and quality systems (eg, GCP, CAP, CLIA, etc)
• Proven rich experience of delivery and use of data for diagnostic projects - including quality control, test data monitoring and troubleshooting
• Intensive experience of working with diagnostic partners to drive timely and successful outcomes, through effectively working across internal and external boundaries.
• Pharmaceutics or diagnostic company working experience for clinical trials, and also CRO lab management experience
• Excellent knowledge in Tissue diagnostic technologies (IHC, FISH, Dual-ISH, etc.) and also scientific literature with deep understanding in diagnostic related area demonstrated through publications in peer reviewed journals.
• Experience in healthy authority Inspection