Diagnostic Scientist (Tissue Diagnostics - Clinical Sciences).
Position: Diagnostic Scientist (Tissue Diagnostics - Clinical Sciences), Precision Medicine & Genomics
Salary: Competitive with excellent benefits package
Can you combine your technical expertise in tissue diagnostic assay development, knowledge of the drug discovery and companion diagnostic co-development process with experience in clinical trial set-up and monitoring? 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.
The Diagnostic Scientist will:
- set-up of new tissue diagnostic (IHC, FISH) assays for clinical trials with patient selection in testing laboratories globally. Working with internal and external partners in a global multi-disciplinary environment with the application of scientific, technical and operational expertise
- monitor diagnostic test data 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
- 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:
- At least a BSc or equivalent in pharmacology, biochemistry, molecular pathology or a related discipline
- Excellent organisational skills, with the proven ability to deliver high quality work on time in full
- Experience of drug discovery and development
- Experience of clinical trial set up and monitoring
- Understanding of analytical and clinical validation activities for IVD devices/assays
- Knowledge of clinical testing procedures and applicable laboratory testing regulations such as GCP, CLIA
- Extensive experience with tissue based biomarker assays, such as immunohistochemistry (IHC) and/or in situ hybridisation (ISH), including troubleshooting and QC
- Expertise in tissue based biomarker assays as demonstrated through publications in peer reviewed journals
- 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.
Desirable Qualifications, Skills and Experience:
- Knowledge of CRO, testing laboratories software packages (LIMS based, Web based systems used for sample tracking & data reporting)
- Clinical study set-up and documentation
- 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 technical experience and strategic understanding of tissue diagnostics.
Applications Open: 6th October 2017
Applications Close: 6th November 2017