Typical Accountabilities

• Build and lead a team to deliver diagnostic testing and translational science activities for all non-oncology Translational Medicine (TM) clinical studies as agreed with TMLs and TM leadership including: diagnostic test establishment in partner laboratories, monitor diagnostic test data for quality control, prepare study reports for presentation. Accountable for scientific and regulatory aspects of non-oncology TM activity in third-party multi-disciplinary clinical laboratories and proffered alliance partners. 
• Formulate clinical translational biomarker plan, and ensure individual clinical studies fits China-specific requirements, including HGR, and translational strategy by supporting TMLs in scientific and technical aspects of diagnostic test development with respect to deployment in China, including: Protocol drafting, recommendations of diagnostic systems, laboratories and/or partners for local testing options, and ensure TM non-China team are delivering appropriately to China-specific clinical and diagnostic objectives. China-strategy to be agreed by product teams working closely with the clinical team and other supporting functions. 
• Support analysis of TM data generated in China including genetic analyses and interpretation across AstraZeneca's portfolio and engage and leverage Translational Medicine expertise where novel technologies or vendors are being considered. 
• Be the TM lead on selection and partnering with academic centers of excellence; liaising with TM colleagues as well as our External R&D and Partner-Of-Choice leads. 
• Lead 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. 
• Provide and/or support scientific troubleshooting on biomarker assays with input from TMLs and technical experts. 
• Support regulatory submissions and regulatory interactions as needed
• Present internal/ external communications on TM China-specific testing and trials; liaise with TML's with overall responsibility for individual projects to develop communications plan. 
• Establish and manage relationships with academic and commercial KOL's to implement these non-oncology TM diagnostic testing and translational science activities 

Education, Qualifications, Skills and Experience

Essential

• Ph.D. in a relevant discipline, significant experience in the biopharmaceutical industry and drug development process
• Well-developed understanding of biosignatures and biomarker analysis
• Demonstrable experience of analytical diagnostic assay validation and use in a clinical testing setting. 
• Broad knowledge of scientific literature with deep understanding in diagnostic biomarker related area demonstrated through publications in peer reviewed journals.  
• 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 use 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, 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 

Desirable

• Broad experience in multiple Biopharma TA