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Oncology Translational Medicine Operations Lead

Lieu Gaithersburg, Maryland, États-Unis Job ID R-081665 Date de publication 05/13/2020

Oncology Translational Medicine Operations Lead

Gaithersburg, MD

AstraZeneca is a global biopharmaceutical company. We are dedicated to discovering, developing, and delivering innovative, significant medicines and healthcare solutions that enrich the lives of patients. In AstraZeneca Oncology, our goal is to be at the forefront of developing the next generation of cancer therapies.

A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.

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 early oncology studies Translational medicine are responsible for the biomarker strategy and implementation which includes all exploratory analyses of clinical trial samples and prospective testing for trial recruitment where required.

You will work closely with the Translational Medicine Leader and diagnostic vendors to develop options for biomarker testing.  You will also work closely with the clinical study team to implement the selected options, monitoring ongoing activities to ensure quality of data output.

In this role you will be accountable for ensuring that all activities are delivered demonstrating behaviors and values aligned to AstraZeneca Code of Conduct and supporting policies, standards and procedures, including compliant management of budget, safety, health and environment.

  • Lead the delivery of the biomarker plan for individual clinical studies, ensuring that is based on translational strategy led by translational medicine leader and agreed by product teams working closely with the clinical team and other supporting functions.
  • 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 study documents such as communication, quality management and issue escalation plans
  • 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.
  • Provide dedicated Translational Medicine Alliance Management support 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 Requirements:

  • Bachelor's degree required, with at least 5 years of relevant experience in the biopharmaceutical industry
  • Demonstrable experience of analytical diagnostic assay validation and use in a clinical testing setting.
  • Excellent knowledge of scientific literature with deep understanding in diagnostic related area demonstrated through publications in peer reviewed journals.
  • Knowledge of clinical testing procedures and applicable laboratory testing regulations such as Good Clinical Practice, CAP/CLIA, Good Clinical Practice and Quality Systems Regulation)
  • Proven experience of delivery and use of data for biomarker projects - including quality control, test data monitoring and troubleshooting
  • Experience of working with testing 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.

Preferred Background:

  • Ability to identify risks and escalate appropriately
  • Masters / PhD or equivalent experience in a relevant subject
  • An understanding of drug and companion diagnostic assay co-development and experience working in early and late phase projects.
  • Understanding of related areas e.g. segmentation tool discovery, drug-diagnostic co-development.

Skills & Capabilities

  • 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

Next Steps – Apply today!

To be considered for this great opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a phenomenal fit, please share this posting with them.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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