Translational Medicine delivers 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. 

As a member of translational medicine China team funded from global TM, the role holder be accountable to represent translational medicine function for delivery of robust, scientifically-driven biomarkers across multiple innovative including translationally focused trials, in both MRCTs where China participates as a region and where China team leads. Working with global TM functions, the role holder is responsible for the strategy and implementation of biomarker plan in oncology studies, including all exploratory analyses of clinical trial samples and prospective testing for trial recruitment where required, through 3rd party commercial laboratories in China. The role holder will have line of sight for emerging technologies and their application in clinical setting in AZ pipeline, from data interpretation to insight generation. The role holder is also expected to identify knowledge and data gaps in understanding of cancer disease biology in China, proactively generate data by interacting with academic and clinical investigators.

The role holder is accountable for ensuring that all activities are delivered demonstrating behaviours 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

Represent China translational Medicine in clinical studies. Working with TM Leads (TMLs) in China and globally, and other functions to deliver clinical testing and translational science activities including: input into translational hypotheses in TM strategy, patient selection and translational science assay validation in partner laboratories in China, monitoring assay data for quality control, prepare study reports for presentation. Accountable for scientific and regulatory aspects of TM activity in third-party multi-disciplinary clinical laboratories and alliance partners for designated clinical projects. 

• Provide input into translational hypotheses in clinical programs. Formulate clinical translational biomarker plan, and ensure individual clinical studies fits China-specific requirements, including HGR,  by supporting testing deployment and data generation in China, including: Protocol drafting, recommendations of diagnostic systems, laboratories and/or partners for local testing options.
• Collaborate with and provide scientific expertise to clinical project teams to enable indication selection, early indication of biological activity and patient stratification/selection, especially to address China-specific clinical questions
• Ensure complex clinical assays developed and validated are fit for purpose by working with local vendors and leveraging expertise from global colleagues.
• Contribute to and ensure the quality of Translational Medicine clinical study reports, data reviews and interpretations, presentations, scientific publications and recommendations to development teams and management, including supporting China HGR (Human Genetic Resources) applications for defined TM projects where appropriate 
• Articulate translational medicine strategy and associated detailed activities to support governance. Present internal communications on China-specific testing for defined TM projects; liaise with individual TML's with overall responsibility for individual projects to develop communications plan. Support study investigator meetings by presenting and interpreting translational research data.

• On-board and train fresh TM group members to AZ pipeline, cross franchise overview and specific tumor area strategies, as well as current process and standards, host/organize scientific subteams to develop deep understanding of pipeline-related topics.

Education, Qualifications, Skills and Experience

Essential

• MD/PhD degree required, with at least 7 years of relevant experience in the biopharmaceutical industry with understanding of clinical development process and key activities in translational medicine and how they contribute to achieving business objectives.
• Scientific knowledge in Oncology and literature with experience in biomarker related area(s) demonstrated through publication(s) in peer reviewed journals.  
• Scientific background in immune-oncology and related fields
• Proven records of delivery and interpretation of data for biomarker projects 

Skills & Capabilities

• Ability to communicate to stakeholders on big-picture strategy and detailed plan through oral presentations and progress reports
• Ability to identify risks and escalate appropriately
• Good interpersonal skills and ability to act as an ambassador for TM/AZ internally and externally
• Excellent organisational skills, with the proven ability to deliver high quality work under pressure and against tight timelines

Desirable

• Preclinical research and drug development experiences with demonstrated data interpretation skills;
• Experience of HGR and patient selection assay delivery through clinical research or biopharmaceutical clinical trials

【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机会的企业，我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份（如果适用）及任何其他受法律保护的特征而产生歧视。】