AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
Diagnostic Scientist (Tissue Diagnostics)
At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.
This is an excellent opportunity to be based in our offices at Chesterford Research Park, developing close working relationships with key stakeholders to drive tissue diagnostic science through delivering data analyses which demonstrate the quality of diagnostic testing on AstraZeneca clinical trials, ultimately ensuring the right patients receive the right medicines.
Can you combine your experience in clinical data analysis 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 & Genomics (PMG) function in Cambridge as a Diagnostic Scientist (Tissue Diagnostics), challenge current scientific thinking and make a real difference to patients worldwide, transforming patients’ lives through personalising treatment.
We are investing in a new, state-of-the-art Global R&D Centre and Corporate Headquarters in Cambridge. This will reinforce our position as a world-leading pharmaceutical company and enable us to shape a brand-new vision for our industry. You could be part of this vision, enjoying the facilities to innovate and pursue scientific excellence in your field, and growing your career in a culture that fosters multi-functional working and close collaboration with academia.
Main Duties and Responsibilities:
Precision Medicine and Genomics (PMG) within AstraZeneca focuses on matching medicines to those patients who will benefit from them most and delivers tissue-based companion or complimentary diagnostic assays that align with the drug development process and enhance personalised healthcare approaches in our drug portfolio.
Your role will be to:
- You will influence both AZ diagnostic strategy and the external testing community through delivery of exploratory analyses of diagnostic biomarker data from commercial and AZ clinical trial samples
- Ensure the quality of the diagnostic testing being carried out by testing labs for delivery to clinical studies.
- You’ll enable diagnostic approval in -line with approval of targeted therapeutic through delivering work packages which inform submissions to regulatory authorities
- You will manage projects across internal and external partners in a global multi-disciplinary environment with the application of scientific, technical and operational expertise
- Develop a strategic understanding of the diagnostic testing landscape
- You’ll ensure 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
Your Key Responsibilities Will Include:
- Preparation and review of documentation including statistical analysis and data monitoring plans.
- Planning and conducting analyses of diagnostic testing data from commercial and AZ clinical trial samples and managing the delivery of outsourced analysis projects
- Development, maintenance and documentation of robust statistically validated tools as appropriate to enable the analysis of data either by yourself or by other scientists
- Data monitoring, management and quality control for ongoing clinical studies
- Preparation of study reports and their presentation at study team meetings
- Preparation of journal publications and conference presentations
- Working within both study and diagnostic teams to deliver data suitable for submission to regulatory authorities
Essential Qualifications, Skills and Experience:
- At least a BSc or equivalent in a statistics, informatics or related discipline
- Data management and statistical analysis (experience in one of the following: R, SPSS, SAS, Minitab, Matlab)
- Experience of developing and delivering validated data analysis tools/scripts
- Excellent organisational skills, with the proven ability to deliver high quality work on time in full
- Ability to communicate with stakeholders for study updates, testing progress 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
- Knowledge of tissue-based biomarker assays, such as immunohistochemistry (IHC) and/or in situ hybridisation (ISH)
- Knowledge of Spotfire or other visualisation tools
- 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.
If you are interested, please apply.
Location: Cambridge, UK.
Salary: Competitive + excellent benefits
Closing date: Tuesday 23rd April 2019
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.