Biopharma Translational Medicine (Associate) Principal Scientist Full-time

Translational Medicine Scientist

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.