Translational Medicine Senior Scientist/Associate Principle Scientist
Support Early Oncology Translational Medicine (EO-TM) 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.
In EO studies Translational Medicine are responsible for the biomarker strategy and implementation, which includes all exploratory analyses of clinical trial samples and prospective testing for trial recruitment where required.
Reporting into China R&D and funded from global TM the role holder will support patient selection testing and translational science data generation through 3rd party commercial and academic laboratories. The role holder will work under the supervision of the Head of Translational Medicine China and with individual TM study leads on developing the China-specific options for biomarker testing and the implementation of testing via 3rd party laboratories. They will work with 3rd party laboratories to develop testing QC plans and closely monitor test quality and will support adherence to China HGR regulations. They will also interface with other AZ China teams including; PMB, Partners-of-Choice and China Medical Affairs, Biosamples lab in Shanghai (PK, ADA), etc.
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.
Lead on China-specific activities related to Early Oncology (EO) Translational Medicine (TM) clinical studies. Working with the Head of China TM, TM Leads (TMLs) and other functions e.g Precision Medicine to deliver diagnostic testing and translational science activities as agreed with TMLs and TM leadership including: 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 EO TM activity in third-party multi-disciplinary clinical laboratories and proffered alliance partners for your designated clinical projects.
• Ensure biomarker plan for 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.
• Responsible for QC and monitoring analysis and preparation of study reports for data generated in China on defined EO TM projects; engaging with and 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 diagnostic assays. Responsible for new Laboratory setup and auditing/proficiency testing; understanding their challenges, and building relationships to work effectively with them on continuous improvement.
• Lead selection and partnering with academic centers of excellence for defined China EO TM projects; liaising with TM colleagues and External R&D and Partner-Of-Choice functions.
• Provide scientific and regulatory diagnostic expertise to clinical project teams including supporting China HGR (Human Genetic Resources) applications for defined EO TM projects and highlight specific HGR training where appropriate
• Align with China Precision Medicine (PMB) on testing strategy to ensure smooth transition of biomarker testing from early to late-stage; contribute business intelligence to a knowledgebase of China-specific current and emerging biomarker assay technologies and partners (academic & commercial) with PMB colleagues.
• Accountable for contracting, project management and study monitoring for defined EO 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 scientific troubleshooting on biomarker assays as required with input from TMLs and technical experts.
• Present internal/external communications on China-specific testing for defined EO TM projects; liaise with individual TML's with overall responsibility for individual projects to develop communications plan.
• Maintain relationships with academic and commercial KOL's delivering EO TM diagnostic testing and translational science activities
Education, Qualifications, Skills and Experience
• Bachelor's degree required, with at least 2 years of relevant experience in the biopharmaceutical industry
• Significant 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 scientific literature with experience in biomarker related area(s) demonstrated through publication(s) 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)
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
• Ability to work independently, designing, executing and interpreting tasks
• 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
• Willingness to travel both nationally and internationally if required
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.
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.