職位描述
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.The role holder will work closely with the Translational Medicine Lead and diagnostic vendors to develop options for biomarker testing. The role holder will also work closely with the clinical study team to implement the selected options, monitoring 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. Typical Accountabilities * Support the delivery and execution of the biomarker plan for clinical studies, ensuring that is based on translational strategy led by translational medicine leader working closely with the clinical team and other supporting functions. * Manage external alliance, support China TM activities including assay transfer, vendor evaluation and collaborations; 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 timeliness 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 biosafetey laws, and address instances of non-compliance. Education, Qualifications, Skills and ExperienceEssential * 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 appropriatelySkills & 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 organisational skills, with the proven ability to deliver high quality work under pressure and against tight timelinesDesirable * 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. * Understandings for Human Genetic Resource regulations and previous experiences in application, amendment and submission processes.【AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised. 阿斯利康是一家提供平等機會的企業，我們將考慮所有符合條件的求職者就業。不因殘疾、性別或性取向、懷孕或產假狀況、種族或民族或族裔出身、年齡、宗教或信仰、性別認同或變更、婚姻或伴侶關系、受保護的退伍軍人身份（如果適用）及任何其他受法律保護的特征而產生歧視。】
