At AstraZeneca we win through science, it's at the heart of our every success. That science is only possible when we all work together - we'll always make sure you're clear about how your role is connected to our wider mission to really show what science can do.
The Head of Point-of-Care (PoC) Diagnostics is accountable for building internal expertise, laboratory capability and strategic partnering to deliver regulatory approved point-of-care Diagnostic tests. You will achieve this by providing access to a range of 'multiomic' point-of-care diagnostic platforms that can be applied in a healthcare setting or at home.
The aim of this role is to ensure that the AstraZeneca portfolio is provided with analytically validated and regulatory approved diagnostic tests using point-of-care technology where appropriate enabling approval of linked therapeutics and life cycle management.
The role requires a high degree of functional knowledge to generate and implement strategies for point-of-care Diagnostic test development and regulatory approval in key markets. Working closely with internal Diagnostic Experts and commercial teams throughout AstraZeneca, you will use highly developed communication skills, and represent the function both internally and externally at governance.
You'll work collaboratively with scientists and senior leaders in the Precision Medicine function to embed PoC approaches within drug project teams. The role holder is accountable for ensuring that the role and responsibilities are delivered demonstrating behaviours and values aligned to AstraZeneca Code of Conduct and supporting policies, standards and procedures; including accountability for compliant management of Budget, Safety, Health and Environment.
Accountabilities/Responsibilities, what you will be doing:
- Provide strategic leadership for the Point-of-Care (PoC) Diagnostics discipline within Precision Medicine and the wider AZ organization. Communicate a clear and inspirational strategic vision based on a long-term view of the capability.
- You will implement a strategy to embed point-of-care diagnostic approaches into clinical trials, to maximise opportunities for regulatory submission and commercialisation (in alignment with internal project demands and the evolving external regulatory and healthcare environment).
- Act as key subject matter expert on emerging PoC scientific and regulatory trends in the light of project demand, competitor knowledge, scientific understanding and regulatory environment.
- You'll attract, recruit, and retain top talent and scientific expertise. Lead performance management and professional development of group members through coaching, mentoring, and motivating.
- Drive processes for analytical validation and delivery of validated PoC Diagnostics tests for use in clinical trials, regulatory submission and commercialisation according to international regulatory standards.
- You will work collaboratively with the Precision Medicine function and other stakeholders to provide PoC solutions, working across boundaries and courageously addresses issues which may inhibit effective collaboration.
- Monitor and ensure compliance with all AstraZeneca Policies and Standards and immediately address instances of non-compliance. Deliver ethical and compliant management of Budget, Safety, Health and Environment within the group and on behalf of the function as required.
- Contribute to the performance of Precision Medicine Laboratories as a leadership team member, driving overall strategy and organisational infrastructure improvements.
- Contribute expertise to advise disease areas and project teams for opportunities where point of care diagnostics provides business value.
- PhD or equivalent experience in relevant subject with peer reviewed publications in high quality journals (Impact Factor >5).
- Proven experience in leading PoC development to achieve successful regulatory approval.
- Direct experience of regulatory interactions or preparation of regulatory datasets.
- Broad knowledge across our core therapy areas of Oncology, Cardiovascular Renal & Metabolism (CVRM) and Respiratory, Inflammation and Autoimmunity (RIA).
- Knowledge spanning the use of 'multiomic' PoC diagnostic platforms.
- Experience of delivering complex projects through collaboration with diagnostic partners.
- Proven leadership ability and line management experience - demonstrate excellence in the recruitment, retention, development and motivation of groups of highly qualified scientists.
- Proven record of leading successful teams and functions globally.
- Able to act as a representative for the function within AstraZeneca interacting effectively with key stakeholders and senior leaders.
- Able to represent AstraZeneca externally in interactions with regulatory authorities and key external experts (to the level of Food and Drug Administration (FDA) advisory committee hearings, or European Medicines Agency oral hearings) and at top level scientific meetings.
- Experience of delivering and working to good clinical practice (GCP) and other regulatory standards (CAP/CLIA & Quality Standard Regulation) across the major markets.
- An understanding of drug and companion diagnostic assay co-development and commercialisation and experience working in early and late phase projects.
- Understanding of reimbursement and Payer strategies for PoC diagnostic tests.
Location: Cambridge, UK
Salary: Competitive + Excellent benefits
Closing Date: 20th September 2020
Next steps, if you feel you are suitable for the role please apply!