OPERATIONS LEAD, ONCOLOGY TRANSLATIONAL MEDICINE

Job Description 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 external (Third Party) laboratories.
The Operations Lead  in the Biomarker Operations Group will support TM  with outsourced biomarker testing on samples from patients in global oncology 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.
Typical Accountabilities Set up and oversee biomarker testing work packages at Third Party Laboratories, for individual global clinical studies, aligning with the Translational Medicine Lead and other TM Operations team members, and working closely with the clinical team and other supporting functions.
With supervision, support  set up of  central confirmation testing of biomarkers used for patient selection, and  some secondary and exploratory biomarker endpoints.
Support multiple clinical studies simultaneously (typically 2 or 3 depending on complexity) Work effectively with Procurement and other functions to ensure contracts (SOWs)  for biomarker testing commit CROs/labs to deliver timely, fit-for purpose laboratory testing, compliant with clinical sample testing guidelines.
Contribute to the creation, amendment  and maintenance of relevant study documents such as communication, quality management and issue escalation plans, monitoring plans, and contribute to Trial Master File (eTMF).
Ensure data transfer requirements are defined for exploratory data.
Coordinate sample shipments for retrospective analyses following AZ HBS Compliance & Governance processes for confirmation of consent and authorisation for use.
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.
Ensures own work is compliant  with all AstraZeneca Policies and Standards, and local law/regulation, and address instances of non-compliance.
Essential Bachelor's degree in relevant subject Relevant experience working with clinical samples Understanding of science in relevant areas (e.
.
diagnostics, cancer biomarkers, genomics, oncology therapeutics) Ability to work 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 Desirable Master’s degree in a related field Experience working in oncology clinical trials.
Experience of delivering clinical biomarker testing.
Relevant experience in the biopharmaceutical industry Experience of outsourcing work packages with commercial partners, developing Statements of Work Knowledge of clinical testing procedures and applicable laboratory testing regulations such as Good Clinical Practice, CAP/CLIA, and Quality Systems Regulation 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.