Position: Diagnostic Scientist (Tissue Diagnostics
Clinical Sciences), Precision Medicine & Genomics.
Salary: Competitive with excellent benefits
To register your interest, please apply with your CV and a covering letter.
This is an excellent opportunity to be based in our offices at Chesterford Research Park, developing close working relationships with key stakeholders to manage and implement diagnostic testing set-up for AstraZeneca clinical trials.
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 & Genomics (PMG) 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.
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:
- Manage relationships with global testing facilities to implement new diagnostic assays for clinical trials.
- Managing projects across internal and external partners in a global multi-disciplinary environment with the application of scientific, technical and operational expertise
- Monitor diagnostic test data from the labs and quality control 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
- 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:
- Transfer the diagnostic assay in laboratory testing networks to enable its delivery within a clinical study setting.
- Preparation and review of documentation
- Project management; 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
- Work within both study and diagnostic teams to deliver data suitable for submission to regulatory authorities
Essential Qualifications, Skills and Experience:
- 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 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 Organisations
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), including troubleshooting and QC
- Data management and statistical analysis (experience in one of the following: R, SPSS, SAS, Minitab)
- Knowledge of Spotfire, Matlab.
- 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 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.