職位描述
RESPONSIBILITIES: * Lead innovative diagnostic science to fulfil Precision Medicine approaches. * Lead the delivery of diagnostic testing to clinical studies as agreed with project leaders including: diagnostic test establishment in partner laboratories, monitor diagnostic test data for quality control, provide scientific troubleshooting when necessary and preparation of study reports with presentation at appropriate meetings. * Lead the delivery of diagnostic data work packages to enable regulatory submission and approval inclusive of studies to enable market adoption and life cycle management. * Manage projects across internal and external partners in a global multi-disciplinary environment, applying scientific, technical and operational expertise. Identify opportunities, propose solutions and work across boundaries in the scientific area(s) of expertise that will enable drug development projects and diagnostics labeling. * Build and maintain a knowledge of current and emerging diagnostic assay technologies in area of expertise. * Drive continuous improvement in the scientific area(s) of expertise, aligned to Precision Medicine strategic objectives of increasing project success, adding value to projects and delivering better medicines to patients. * Be accountable for the time, cost and quality of agreed deliverables. * Provide updates on the progress, risks and opportunities of the agreed deliverables to the appropriate governance bodies for review, challenge and issue resolution. * Takes on small supervisory or skills transfer / training roles * Monitor and ensure compliance with all AstraZeneca Policies and Standards, and local law/regulation, and immediately address instances of non-compliance. REQUIRMENTS: * 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 diagnostic projects for regulatory submissions - including quality control, test data monitoring and troubleshooting * Experience of working with diagnostic 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 * Good interpersonal skills and ability to act as an ambassador for Precision Medicine internally and externally * Capability of fluently English communication and writing * 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 * Knowledge of, and enthusiasm for, the aims and objectives of personalised healthcare * Willingness to travel both nationally and internationally * An understanding of drug and companion diagnostic assay co-development and commercialisation and experience working in early and late phase projects * Experience of leading projects within a diagnostic or drug development organisation. * Understanding of related areas e.g. segmentation tool discovery, drug-diagnostic co-development, partnering and commercialisation. * Understand the principle of molecular diagnostics (such as PCR and NGS) methodology. * Understand the scientific rationale of biomarker testing.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。
