Diagnostic Scientist (Tissue Diagnostics)
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceutical and the supply of healthcare services. Working at AstraZeneca means being ambitious, thinking big and working together to make the impossible a reality. At AstraZeneca, we’re proud to have an outstanding workplace culture that encourages innovation and positive collaboration. Here, employees are empowered to express different perspectives and are made to feel valued, energized and rewarded for their ideas and creativity. We are investing in a state-of-the-art research centre in Cambridge where we will bring together some of the finest talent in business and academia.
Can you combine your experience in clinical trial set-up and monitoring with an understanding of assay development and knowledge of the drug discovery and companion diagnostic co-development process? This is an exciting time to join AstraZeneca’s Precision Medicine (PM) function in Cambridge as a Diagnostic Scientist (Tissue Diagnostics - Clinical Sciences), challenge current scientific thinking and make a real difference to patients worldwide, transforming patients’ lives through personalising treatment.
An excellent opportunity has arisen to be based in our offices at Chesterford Research Park, developing close working relationships with key partners to lead and implement diagnostic testing set-up for AstraZeneca clinical trials.
Main Duties and Responsibilities
Precision Medicine (PM) 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 improve personalised healthcare approaches in our drug portfolio.
Your role will be to:
Please note this is NOT a lab-based role.
- Set-up of new tissue diagnostic (Immunohistochemistry (IHC) and In situ Hybridization (ISH) assays for clinical trials with patient selection in testing laboratories globally.
- Manage relationships with global testing facilities to implement these new diagnostic assays for clinical trials.
- Lead projects across internal and external partners in a global multi-disciplinary environment with the application of scientific, technical and operational expertise
- Monitor diagnostic assay data from the testing facilities and quality control this data for the delivery to clinical studies
- Deliver work packages, including submission to regulatory authorities, to enable diagnostic approval in-line with approval of targeted therapeutic
- Develop a strategic understanding of the diagnostic testing landscape
- Ensure that all activities are delivered demonstrating behaviours and values aligned to AstraZeneca Code of Conduct and supporting policies, standards and procedures
Your Key Responsibilities Will Include:
- Transfer of the diagnostic assay to testing laboratories for delivery within a clinical study setting.
- Project oversight, including; preparation and review of documentation, data monitoring, management and quality control for ongoing clinical studies
- Technical troubleshooting of the diagnostic assay
- Preparation of study reports and their presentation at study team meetings
- Working within both study and diagnostic teams to deliver data suitable for submission to regulatory authorities
Essential Qualifications, Skills and Experience:
- Knowledge of tissue-based biomarker assays, such as immunohistochemistry (IHC) and/or in situ hybridisation (ISH), including troubleshooting and QC
- Operational experience of clinical trial set up, documentation and monitoring
- At least a BSc or equivalent in a biological science-based subject
- Excellent organisational skills, with strong ability to deliver high quality work on time and in full
- Clear communication with partners through oral presentations and progress reports
- Ability to collaborate with and influence internal and external partners
- Willingness to travel both nationally and internationally
- Experience of working with, or in a Clinical Research Organisation
Desirable Qualifications, Skills and Experience:
- Experience of drug discovery and development
- Knowledge of clinical testing procedures and applicable laboratory testing regulations such as GCP, CLIA
- Data management and statistical analysis (experience in one of the following: R, SPSS, SAS, Minitab, GraphPad Prism)
- Experience of data visualisation tools (EGSpotfire)
- Exposure to working within a technically regulated environment
- An understanding of drug and companion diagnostic assay co-development and commercialisation
- Experience of working within a global team
- Experience of working with regulatory authorities
We would also like to hear from those with strong clinical trial experience and strategic understanding of tissue diagnostics.
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.