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 translational science test deployment 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 by following established TM strategy, 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
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.
Essential
Education, Qualifications, Skills and Experience
MD/PhD degree required, with at least 5 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 translational science findings and impact 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 and scientific background in immun-oncology and related fields
Experience of HGR and patient selection assay delivery through clinical research or biopharmaceutical clinical trials
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