Translational Medicine Senior Operations Lead – Astrazeneca Jobs

Website AstraZeneca

Job Description:

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.

Job Responsibilities:

  • Review and approve sample instructions for clinical sites.
  • Ensure relevant sample meta-data effectively captured in clinical database.
  • 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.
  • Lead the creation and maintenance of relevant study documents such as communication, quality management and issue escalation plans, and contribute to Trial Master File.
  • 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.
  • Engage and leverage Translational Medicine expertise where novel technologies or vendors are being considered.
  • Ensure the frequency and content of data outputs for patient selection and/or exploratory measures are delivered as agreed with vendor and clinical team.
  • 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.
  • 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.
  • Monitor and ensure compliance with all AstraZeneca Policies and Standards, and local law/regulation, and address instances of non-compliance.
  • Ensure regulatory function supplied with relevant testing data to support risk determination assessment.

Job Requirements:

  • Ability to influence within own discipline and apply constructive challenge.
  • A confident team player who is assertive but willing to listen and learn from the views of others.
  • 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.
  • Good interpersonal skills and ability to act as an ambassador for TM/AZ internally and externally.
  • Ability to work independently, designing, executing and interpreting tasks.
  • Can identify and address critical issues in the context of strategic direction.
  • Ability to interact successfully with multiple customers across functional boundaries.
  • Ability to identify risks and escalate appropriately.
  • Ability to communicate with stakeholders for study updates, testing progress through oral presentations and progress reports.

Qualification & Experience:

  • Excellent knowledge of scientific literature with deep understanding in diagnostic related area.
  • Bachelor’s degree required, with relevant experience in the biopharmaceutical industry
  • Experience of working with external partners to drive timely and successful outcomes, through effectively working across internal and external boundaries.
  • Knowledge of clinical testing procedures and applicable laboratory testing regulations (such as Good Clinical Practice, CAP/CLIA, Good Clinical Practice and Quality Systems Regulation)

Job Details:

Company: AstraZeneca

Vacancy Type: Full Time

Job Location: Cambridge, England, UK

Application Deadline: N/A

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