AstraZeneca

Support Early and late Oncology Translational Medicine activities in China, and ex-China Translational Medicine staff, on defined China-specific projects. 

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 will support patient selection testing and translational science data generation through 3rd party commercial and academic laboratories. Working with global TM study leads, the role holder is responsible for the implementation of biomarker plan in oncology studies, including all exploratory analyses of clinical trial samples and prospective testing for trial recruitment where required.

The role holder will evaluate novel technology provider, work with 3rd party laboratories to develop testing QC plans and closely monitor test quality and will support adherence to China HGR regulations. 

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

Support China-specific activities related to Translational Medicine (TM) clinical studies: patient selection and translational science test establishment in partner laboratories, 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. 

• Formulate clinical translational biomarker plan, and ensure individual clinical studies fits China-specific requirements, including HGR, by supporting TMLs in with respect to clinical testing deployment in China, including: Protocol drafting, recommendations of diagnostic systems, laboratories and/or partners for local testing options.
• Responsible for QC and monitoring analysis and preparation of study reports for data generated in China on defined TM projects, leveraging Translational Medicine global expertise where novel technologies or vendors are being considered.
• Lead evaluation, selection, due diligence and partnering with 3rd party laboratories for delivery of clinical testing assays. Responsible for new Laboratory setup and auditing/proficiency testing; understanding their challenges, and building relationships to work effectively with them on continuous improvement.
• Provide scientific expertise to clinical project teams including supporting China HGR (Human Genetic Resources) applications for defined TM projects and highlight specific HGR training where appropriate 
• Accountable for contracting, project management and study monitoring for defined TM China projects, working effectively with procurement to contract the biomarker plan to deliver fit-for purpose laboratory testing from sample receipt to delivery of results. 
• 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. 

Education, Qualifications, Skills and Experience

Essential

• Bachelor's degree required, with at least 5 years of relevant experience in the biopharmaceutical industry with understanding of clinical development process
• Scientific knowledge in Oncology and experience of assay validation and use in a clinical testing setting. 
• Experience of delivery and use of data for biomarker projects - including quality control, test data monitoring and troubleshooting 
• Experience with and understanding of genomic technologies including Next Generation Sequencing (NGS)
• Knowledge of clinical testing procedures and applicable laboratory testing regulations such as China HGR (Human Genetic Resources), CAP/CLIA, Good Clinical Practice and Quality Systems Regulation) 

Skills & Capabilities

• Ability to communicate with stakeholders for study updates, testing progress through oral presentations and progress reports 
• Ability to identify risks and escalate appropriately
• Demonstrable skills in communication, stakeholder and project management
• 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

• Masters / PhD or equivalent experience in a relevant subject
• Understanding of the activities involved in Translational Medicine science and how they contribute to achieving business objectives
• Experience of HGR and patient selection assay delivery through clinical research or biopharmaceutical clinical trials
• Preclinical research and drug development experiences
• An understanding of drug and companion diagnostic assay co-development and experience working in early and late phase projects
• Knowledge of scientific literature with experience in biomarker related area(s) demonstrated through publication(s) in peer reviewed journals. 

【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。】

Date Posted

23-2月-2024

Closing Date

29-9月-2024

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.