Do you have expertise in, and passion for Translational Medicine? Would you like to apply your expertise to impact biomarker testing in oncology clinical trials, and advance the quality of data output in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

BUSINESS AREA

Translational Medicine supports programs in all phases of development and focuses on making measurements on human samples to understand why, and identify which, patients benefit from particular treatments, what doses and schedules of treatments to use and the mechanisms underlying the development of resistance to treatment.

In oncology studies Translational Medicine are responsible for the biomarker strategy and implementation which includes all exploratory analyses of global clinical trial samples and prospective testing for trial recruitment where required. 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 cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025. We are empowered to be bold, take calculated risks and use our intelligence and courage to always follow the science. This approach has enabled us to successfully deliver 7 new Oncology medicines in as many years. We are focused on identifying and treating patients earlier, where there is greater curative potential. With the greatest number of early stage cancer trials in the industry, we are getting closer to finding cures every day.

What you’ll do

The role holder will work closely with Oncology Translational Medicine Leads and diagnostic vendors to develop options for biomarker testing. The role holder will work closely with the clinical study team to implement the selected options, monitoring ongoing activities to ensure quality of data output.

The role holder is accountable for 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.

  • Align with the Translational Medicine Lead to deliver the biomarker plan strategy for individual global clinical studies; working closely with the clinical team and other supporting functions.

  • Work with the Diagnostic sub team of the Global Product Team for trials with prospective testing.

  • Engage and leverage Translational Medicine expertise where novel technologies or vendors are being considered.

  • Work effectively with procurement to contract the biomarker operations to deliver fit-for purpose laboratory testing from sample receipt to delivery of results, compliant with clinical sample testing guidelines where necessary.

  • Ensure biomarker plan commits CROs/laboratories to deliver timely, fit for purpose testing with sufficient clarity on input for the clinical team to develop site requirements and contracts for sample logistics.

  • Ensure regulatory function supplied with relevant testing data to support risk determination assessment

  • Lead the creation and maintenance of relevant study documents such as communication, quality management and issue escalation plans, and contribute to Trial Master File.

  • Ensure the frequency and content of data outputs for patient selection and/or exploratory measures are delivered as agreed with vendor and clinical team

  • Ensure relevant sample meta-data effectively captured in clinical database

  • Review and approve sample instructions for clinical sites

  • Monitor biomarker data quality and timeliness via agreed QC plan, provide scientific troubleshooting when necessary

  • Build and maintain a knowledge of current and emerging biomarker assay technologies in area of expertise.

  • Be accountable for the time, cost and quality of agreed deliverables.

  • Work with Translational Medicine Alliance Management for assigned vendor(s) as needed, working with Scientific Program Manager for matters requiring escalation

  • Monitor and ensure compliance with all AstraZeneca Policies and Standards, and local law/regulation, and address instances of non-compliance.

Essential for the role

  • Bachelor’s degree required, with relevant experience in the biopharmaceutical industry

  • Excellent knowledge of scientific literature with deep understanding in diagnostic related area.

  • Knowledge of clinical testing procedures and applicable laboratory testing regulations (such as Good Clinical Practice, CAP/CLIA, Good Clinical Practice and Quality Systems Regulation)

  • Experience of working with external partners to drive timely and successful outcomes, through effectively working across internal and external boundaries.

  • Ability to communicate with stakeholders for study updates, testing progress through oral presentations and progress reports

  • Ability to identify risks and escalate appropriately

  • Good interpersonal skills and ability to act as an ambassador for TM/AZ internally and externally

  • Ability to interact successfully with multiple customers across functional boundaries

  • Ability to work independently, designing, executing and interpreting tasks

  • Can identify and address critical issues in the context of strategic direction

  • A confident team player who is assertive but willing to listen and learn from the views of others

  • Ability to influence within own discipline and apply constructive challenge

  • Excellent organisational skills, with the proven ability to deliver high quality work under pressure and against tight timelines

  • Willingness to travel both nationally and internationally if required

Desirable for the role

  • Demonstrable experience of analytical diagnostic assay validation and use in a clinical testing setting.

  • Proven experience of delivery and use of data for biomarker projects – including quality control, test data monitoring and troubleshooting

  • Experience of outsourcing work packages with commercial testing partners, developing Statements of Work

  • Masters / PhD or equivalent experience in a relevant subject

  • An understanding of drug and companion diagnostic assay co-development

  • Experience working in early and late phase oncology clinical trials.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

Competitive salary and benefits

Close date: 28th August 2021

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