(Associate) Principal Scientist, Translational Medicine Full-time

Translational Medicine Role

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 be accountable for delivery of robust, scientifically-driven biomarkers across multiple oncology trials. Working with global TM study leads, the role holder is responsible for the strategy and 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 will provide scientific support of academic collaborations.

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. Working with the Head of China TM, TM Leads (TMLs) and other functions to deliver clinical testing and translational science activities including: patient selection and clinical 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.
• Collaborate with and provide scientific expertise to clinical project teams to enable indication selection, early indication of biological activity and patient stratification/selection, especially to address China-specific clinical questions
• Ensure complex clinical assays developed and validated are fit for purpose by working with local vendors and leveraging expertise from global colleagues.
• Contribute to and ensure the quality of Translational Medicine clinical study reports, data reviews and interpretations, presentations, scientific publications and recommendations to development teams and management, including supporting China HGR (Human Genetic Resources) applications for defined TM projects and highlight specific HGR training where appropriate
• 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.
• On-board and train fresh TM group members to current process and standards.

Education, Qualifications, Skills and Experience

Essential

• MD/PhD degree required, with at least 3 years of relevant experience in the biopharmaceutical industry with understanding of clinical development process and key activities in translational medicine and how they contribute to achieving business objectives.
• Scientific knowledge in Oncology and literature with experience in biomarker related area(s) demonstrated through publication(s) in peer reviewed journals.
• Experience of delivery and interpretation of data for biomarker projects

Skills & Capabilities

• Ability to communicate to stakeholders on big-picture strategy and detailed plan through oral presentations and progress reports
• Ability to identify risks and escalate appropriately
• 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

• Preclinical research and drug development experiences with demonstrated data interpretation skills;
• Clinical research experiences in novel modalities (RDC， gene therapy, mRNA vaccine); Scientific background in immun-oncology and related fields;
• Multi-omics data analyses and bioinformatics background; Experiences of foundational models and utility in biomedical science
• Experience of HGR and patient selection assay delivery through clinical research or biopharmaceutical clinical trials

Key Relationships to reach solutions

Internal (to AZ or team)

• Translational Medicine Leaders, Clinical Project Teams, Translational Medicine Technology Groups, Precision Medicine and Biomarkers, Translational Medicine Leadership.

External (to AZ)

• Third parties working on biomarker testing, including clinical service laboratories, diagnostic companies, biotech companies and academic institutions.