Associate Principal Scientist
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 is accountable for delivery of robust, scientifically-driven biomarkers across MRCTs in China. Candidate will contribute to China-specific aspects of TM strategy, support patient selection testing and translational science data generation through 3rd party commercial. 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. Working with TM tech evaluation team, the role holder will implement evaluation of local technology providers, develop testing QC plans and closely monitor test quality and will support adherence to China HGR regulations.
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.
Education, Qualifications, Skills and Experience
Essential
- 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
【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. 阿斯利康是一家提供平等机会的企业，我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份（如果适用）及任何其他受法律保护的特征而产生歧视。】
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.
