Molecular Diagnostics Science Manager

hace 3 semanas

Barcelona, España AstraZeneca A tiempo completo

AstraZeneca delivers companion or complementary diagnostic assays that match medicines to those patients who are most likely to benefit from them. This approach, known as **Precision Medicine**, is based on those individual characteristics that make some patients respond to treatment better than others. We use this knowledge to develop diagnostic tests that doctors can use to help prescribe the best treatment for each patient.

As a **Molecular Diagnostics Science Manager**, you will use your knowledge of **DNA/RNA** molecular assays (qPCR, dPCR, NGS) to provide **scientific,** **technical and clinical operational expertise** to drug project teams following a diagnostics approach.

**The role holder will be accountable for**
- delivery of work packages involving the development of diagnostics as agreed with project leaders
- developing innovative diagnostics science across core therapeutic areas
- scientific and regulatory aspects of diagnostic test establishment in testing laboratories, including delivery and quality control of clinical data packages to enable regulatory approvals to support market adoption and life cycle management.
- ensuring 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.

**Typical Accountabilities, what you will be doing**:

- Lead innovative diagnostic science to fulfil Precision Medicine approaches and deliver diagnostic testing to clinical studies as agreed with project leaders including:

- Technical and scientific input into the diagnostic strategy
- Technical due diligence on diagnostic partner options
- Delivery of technical evaluation of assays/test labs
- Lead diagnostic test establishment in partner laboratories
- QC and Monitor diagnostic test data throughout duration of clinical trial
- Provide scientific troubleshooting when necessary
- Preparation of study reports with presentation at appropriate meetings.
- Lead the delivery of diagnostic data work packages to enable regulatory submission and approval as well as identifying opportunities to remove barriers to real-world diagnostic testing.
- Build and maintain a knowledge of current and emerging diagnostic assay technologies in area of expertise.
- Drive 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.
- Be accountable for the time, cost and quality of agreed deliverables.
- Provide updates on the progress, risks and opportunities of the agreed deliverables to the appropriate governance bodies for review, challenge and issue resolution.
- Takes on small supervisory or skills transfer / training roles
- Monitor and ensure compliance with all AstraZeneca Policies and Standards, and local law/regulation, and immediately address instances of non-compliance.

**Education, Qualifications, Skills and Experience**:
**Essential**:

- Excellent molecular biology skills including experience in Next-Generation Sequencing (NGS), qPCR and/or dPCR, DNA and RNA handling methods and other relevant molecular biology and/or genomics technique.
- Excellent knowledge of scientific literature with deep understanding in molecular biology and/or diagnostic related area demonstrated through publications in peer reviewed journals.
- Knowledge of analytical diagnostic assay validation and use in a clinical testing setting.
- Knowledge of clinical testing procedures and applicable laboratory testing regulations such as Good Clinical Practice, CAP/CLIA, ISO and Quality Systems Regulation
- Knowledge of delivery and use of data for diagnostic development for regulatory submissions, including proven experience of quality control and data monitoring and troubleshooting.
- Experience of working with external partners or collaborators (ideally diagnostic companies) to drive timely and successful outcomes, through effectively working across internal and external boundaries.
- Ability to communicate with cross-functional stakeholders for project updates through oral presentations and progress reports
- Ability to identify risks and escalate appropriately
- Ability to work collaboratively within large cross-functional team(s) including multiple internal and external partners

**Desirable**:

- An understanding of drug and companion diagnostic assay co-development and commercialisation and experience working in early and late phase projects
- Demonstrable experience of analytical diagnostic assay validation and use in a clinical testing setting.
- Proven experience of delivery and use of data for diagnostic projects for regulatory submissions
- Experience of leading projects within a diagnostic or drug development organisation.
- Experience in computational approaches to data analysis and handling large data set

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