Project Manager, Translational Medicine

SUMMARY OF THE ROLE 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 Scientific Operation program managers are responsible for the implementation of biomarker strategy which includes all exploratory analyses of clinical trial samples and prospective testing for trial recruitment where required. The role holder will work closely with the Translational Medicine Lead and clinical assay vendors to develop options for biomarker testing. The role holder will also work closely with the clinical study team to implement the selected options, monitor ongoing activities to ensure quality of data output. The role holder is 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. ROLE & RESPONSIBILITIES • Support the delivery and execution of the biomarker plan for clinical studies, ensuring that is based on translational strategy led by Translational Medicine Lead (TML) and work closely with the clinical team and other supporting functions. • Manage external alliance, support China TM activities including assay transfer, vendor evaluation and management; 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 clinical testing; Lead the creation and maintenance of study documents such as communication, quality management and issue escalation plans • Ensure HGR compliance by supporting HGR application, tracking study-related approvals, assure compliance of on-going and legacy studies, sample management. • Review and approve sample instructions for clinical sites when necessary; Monitor biomarker data quality and timeline via agreed QC plan; Be accountable for the time, cost and quality of agreed deliverables. • Monitor and ensure compliance with all AstraZeneca Policies and Standards, HGR regulations and China biosafety laws, and address instances of non-compliance. • Proactively contributes to the optimization of existing as well as development of new processes to ensure best practice and is willing to utilize digital tools to improve operational efficiency. • Establish key relationships to reach solutions, Internal to AZ or team: Translational Medicine Leads, Clinical Project Teams, Quality Assurance, Precision Medicine and Biosampling, and external: Third parties working on biomarker testing, including clinical service laboratories, contract research organizations, diagnostic companies, biotech companies and academic institutions. REQUIREMENTS Essential • Bachelor's degree required, with at least 7 years of relevant experience in the biopharmaceutical industry • Demonstrable experience of analytical diagnostic assay validation and use in a clinical testing setting. • 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 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 • Ability to identify risks and escalate appropriately Skills & Capabilities • Good interpersonal skills and ability to act as an ambassador for TM/AZ internally and externally • Ability to effectively communicate and interact successfully with multiple customers across functional boundaries • A confident team player who is assertive but willing to listen and learn from the views of others • Excellent organizational skills, with the proven ability to deliver high quality work under pressure and against tight timelines Desirable: • Masters / PhD or equivalent experience in a relevant subject • PMP certified preferred • An understanding of drug and companion diagnostic assay co-development and experience working in early and late phase projects • Understandings of related areas e.g. segmentation tool discovery, drug-diagnostic co-development. • Understandings for Human Genetic Resource regulations and previous experiences in application, amendment and submission processes. Date Posted 16-12月-2025 Closing Date 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.