Senior Operations Lead, Oncology Translational Medicine
Job Type: Full time
Location: Barcelona, Mississauga, or Cambridge.
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 disease. But we’re more than one of the world’s leading pharmaceutical companies.
At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most demanding situations because we are committed to doing the right thing. We put patients first and follow the science to bring life-changing medicines to patients that need them.
About the role and the project
Oncology is a core therapy area and growth platform at AstraZeneca and our vision is to deliver life-changing medicines that improve outcomes for patients most in need.
Oncology Translational Medicine (TM) supports programs in all phases of clinical cancer drug development. TM are responsible for the biomarker strategy and implementation, which includes analyses of global clinical trial samples. The aim is 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. The Translational Medicine Biomarker Operations Group’s remit is to deliver this clinical biomarker testing, using 3rd party laboratories.
The Senior Operations Lead in the Biomarker Operations Group will support TM with set-up, oversight and closure of prospective testing for patient selection for entry to global early phase oncology trials. They will also lead delivery of secondary and exploratory biomarker endpoints on selected early and late phase trials.
They are 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.
Set up and oversee biomarker testing work packages at third-party laboratories, for individual global clinical studies, aligning with the Translational Medicine Lead, and working closely with the clinical team and other supporting functions.
Work effectively with Procurement and other functions to ensure contracts for biomarker testing commit CROs/labs to deliver timely, fit-for purpose laboratory testing, compliant with clinical sample testing guidelines.
During trial set-up, provide timely information to the clinical team on sample collection requirements at sites, and on sample logistics.
Ensure Regulatory function is supplied with relevant testing data to support Risk Determination assessment and IVDR submissions.
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 relevant sample meta-data are effectively captured in clinical database and that data transfer requirements are defined for exploratory data.
Oversee the delivery of biomarker testing, ensuring the frequency and content of data outputs for patient selection and/or exploratory measures are delivered as agreed, monitoring via an agreed QC plan.
Develop good relations with 3rd party labs, maintaining timely and clear communications, and understanding appropriate routes for matters requiring escalation.
Build and maintain a knowledge of current and emerging biomarker assay technologies in area of expertise.
Monitor and ensure compliance with all AstraZeneca Policies and Standards, and local law/regulation, and address instances of non-compliance.
Bachelor's degree in relevant subject
Relevant experience in the biopharmaceutical industry or clinical institution
Deep understanding of science in relevant areas (e.g. diagnostics, cancer biomarkers, genomics, oncology therapeutics)
Experience of working with partners to drive timely and successful outcomes, through effectively working across internal and external boundaries.
Ability to interact successfully with multiple stakeholders across functional boundaries, with clear oral and written communication
Ability to work independently, designing, executing and interpreting tasks
A confident team player with good interpersonal skills who is assertive but willing to listen and learn from the views of others, able to influence beyond own immediate team
Excellent organisational skills, with the proven ability to deliver high-quality work under pressure and against tight timelines
Attention to detail coupled with ability to manage and track multiple projects simultaneously
Knowledge of clinical testing procedures and applicable laboratory testing regulations such as Good Clinical Practice, CAP/CLIA, and Quality Systems Regulation
Experience of analytical diagnostic assay validation and/or use in a clinical testing setting.
Experience of delivery and use of data for clinical biomarker projects
Experience of outsourcing work packages with commercial partners, developing Statements of Work
Experience working in oncology clinical trials.
An understanding of drug and companion diagnostic assay co-development
Masters / PhD or equivalent experience in a relevant subject
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 authorization and employment eligibility verification requirements.