Tissue Diagnostic Science Manager

3 tygodni temu

Warsaw, Polska AstraZeneca Pełny etat

Tissue Diagnostic Science Manager

12 Month Fixed Term Contract or Secondment

Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It’s our big vision that unites and inspires us.

With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing ground breaking science with the latest technology to achieve breakthroughs. Backed by investment, we are seeking to deliver 6 new molecular entities by 2025.

A place built on courage, curiosity and collaboration – we make results-oriented decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team.

Pioneers of collaborative research we have built an outstanding scientific community both internally and externally. Fusing academia and industry, we have united some of the world’s foremost medical centres.

Have the opportunity to build an exciting and meaningful career as part of the team committed to improving the lives of millions with cancer.

Precision Medicine and BioSamples 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 enable personalised healthcare approaches within our clinical portfolio.
 

As a Manager, Tissue Diagnostics Science you will use your knowledge of tissue based diagnostic assays including immuno-histochemistry (IHC), in situ hybridization (ISH) and other ground breaking technologies and approaches (multiplexing, multi-immunofluorescence, Digital pathology and artificial intelligence etc.) to provide scientific and technical expertise to deliver innovative tissue diagnostic approaches to AstraZeneca’s clinical portfolio, through strategic partnerships with leading diagnostic companies.

If successful, you would be part of multidisciplinary teams implementing and delivering diagnostic tests to match the right patients to the right drugs. Specifically, you would be:

Delivering diagnostic testing to clinical studies as agreed with project leaders including tissue (IHC, ISH assays) diagnostic test establishment in partner laboratories, establish innovative diagnostic tests ( tests relying on machine learning/AI), monitor diagnostic test data for quality control, provide scientific troubleshooting when necessary and preparation of study reports with presentation at appropriate meetings. Accountable for the operational, scientific and regulatory aspects of establishing and controlling diagnostic tests used to identify patients who are eligible to enter drug clinical trials. Performing technical due diligence of potential external partners ( start-up companies, diagnostic manufacturers, laboratories) in scientific area(s) of expertise. Leading projects across internal and external partners in a global multi-disciplinary environment, applying scientific, technical and operational expertise. Accountable to scout and evaluate emerging technologies in your area of expertise aligned with mid and long term strategic priorities of Precision Medicine. Identify opportunities, propose solutions and work across boundaries in the scientific area(s) of expertise that will enable drug development projects and diagnostics labelling. Generating scientific evidence from a variety of data-types ( images, real-world evidence, clinical trial data) to enable companion diagnostic test selection, regulatory submissions and diagnostic test life-cycle management. Delivering diagnostic data work packages to enable regulatory submission and approval inclusive of studies to enable market adoption and life cycle management, including statistical data analysis. Building and maintaining a knowledge of current and emerging diagnostic technologies in area of expertise. Accountable for the delivery of scientific evidence enabling the development of new diagnostic tests, their regulatory submissions and commercial launches. Driving continuous improvement in the scientific area(s) of expertise, aligned to Precision Medicine strategic objectives of increasing project success, adding value to projects and delivering better medicines to patients. Being accountable for the time and quality of agreed work. Providing updates on the progress, risks and opportunities of the agreed work to the appropriate governance bodies for review, challenge and issue resolution. Taking on small supervisory or skills transfer / training roles

Essential Minimum

BSc or equivalent experience in relevant subject Experience of working in collaborative or multi-functional initiatives Excellent verbal and written communication skills 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 QC / monitoring of tissue testing

Desirable

Advance degree or equivalent experience in a relevant area An understanding of clinical and diagnostic development and commercialisation. Knowledge of clinical testing procedures and applicable laboratory testing regulations such as Good Clinical Practice, CAP/CLIA, Good Clinical Practice and Quality Systems Regulation.

Why we love it

If your passion is science and you want to be part of a team that makes a bigger impact on patients’ lives, then there’s no better place to be. Here we truly understand science and apply it every day to strengthen and grow our pipeline.

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Date Posted

06-cze-2024

Closing Date

19-cze-2024

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