Biopharma Translational Medicine (Associate) Principal Scientist

Typical Accountabilities

• Design and lead strategic, technical and scientific activities of fit-for-purpose translational medicine studies in support of non-oncology programs.
• Design and deliver translational medicine strategies including mechanism of action, prognostic and predictive biomarkers, pharmacodynamics, patient stratification, assets differentiation, resistance mechanism etc. Deep understanding of scientific rationale, clinical sciences and data interpretation across AstraZeneca's portfolio.
• Partner with investigator from hospital or academic to formulate clinical translational medicine plan; ensure individual clinical studies fits China-specific requirements, including HGR. Responsible for protocol drafting, recommendations of diagnostic systems, laboratories and/or partners for local testing options. Work closely with clinical development, clinical operations, regulatory, program management and AstraZeneca's global team to ensure excellence and quality of China-translational strategy and studies.
• Establish and monitor diagnostic test/biomarker assays in partner laboratories, monitor data for quality control, prepare study reports for presentation. Accountable for scientific, troubleshooting and regulatory aspects of biomarker assays/tests in third-party clinical laboratories and preferred alliance partners. Knowledge of novel technologies and vendors.
• Lead and execute contracting, project management and study monitoring on non-oncology 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. 
• Support regulatory submissions and regulatory interactions as needed.
• Establish and manage relationships with academic and commercial KOL's to implement these non-oncology TM diagnostic/biomarkers testing and translational science activities 

Education, Qualifications, Skills and Experience

Essential

• Ph.D. in a relevant discipline including Biochemistry, Cell Biology, Immunology, Metabolism, or a closely related field.
• Minimum 5 years post-Ph.D. experience including at least 3 years of industry experience in a pharmaceutical or biotech company.
• Broad knowledge of scientific principles with deep understanding of disease biology of at least one therapeutic area including respiratory, immunology, endocrinology & metabolic, cardiovascular diseases.
• Understanding of biosignatures and biomarker analysis, experience in diagnostic/biomarker assays development and validation in a clinical testing setting. 
• 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)  
• Proven experience of delivery and analysis of data for biomarker projects - including quality control, test data monitoring and troubleshooting 
• Experience of working with testing partners to drive timely and successful outcomes.
• Ability to communicate with stakeholders for study/progress updates and scientific presentations through oral presentations and progress reports 
• Ability to identify risks and escalate appropriately, multitask, and collaborate
• Good communication skills in both Chinese and English

Desirable

• Proven excellence including high-impact journal publications, conference presentations, delivery of project milestones, etc.
• Excellent scientific acumen and strong hands-on experience in biomarker assays including immune profiling, flow cytometry, tissue imaging and analysis, cell transcriptomics and genomics assays, and other cell based and soluble biomarkers.
• Ability of strategic and creative thinking; multitask, drive, manage, execute and independently deliver results for complex multi-functional projects according to established timelines.
• Passionate for excellent science, open-minded and solution oriented.

【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。】

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 authorisation and employment eligibility verification requirements.