Translational Medicine China Lead
- Bulid and lead a team to deliver diagnostic testing and translational science activities for Early Oncology (EO) Translational Medicine (TM) clinical studies as agreed with TMLs and TM leadership including: diagnostic test establishment in partner laboratories, monitor diagnostic test 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.
- 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, and ensure EO TM non-China team are delivering appropriately to China-specific clinical and diagnostic objectives. China-strategy to be agreed by product teams working closely with the clinical team and other supporting functions.
- Support analysis of EO TM data generated in China including genetic analyses and interpretation across AstraZeneca's Early Oncology portfolio and engage and leverage Translational Medicine expertise where novel technologies or vendors are being considered.
- Be the TM lead on selection and partnering with academic centers of excellence; liaising with TM colleagues as well as our External R&D and Partner-Of-Choice leads.
- Bridge between TM and PMB to ensure alignment on testing strategy from early to late-stage; build and maintain a knowledgebase of china-specific current and emerging biomarker assay technologies and partners with PMB colleagues.
- Lead contracting, project management and study monitoring on 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 and/or support scientific troubleshooting on biomarker assays with input from TMLs and technical experts.
- Evaluate general performance of service lab or candidate lab including Proficiency Testing and lab audit (CLIA, CAP,etc); liaising with PMB colleagues for line-of-sight to assay deployment in late-stage projects?
- Support all TM China HGR (Human Genetic Resources) applications and highlight training where required
- Present internal/ external communications on EO TM China-specific testing and trials; liaise with TML's with overall responsibility for individual projects to develop communications plan.
- Establish and manage relationships with academic and commercial KOL's to implement these EO TM diagnostic testing and translational science activities
Approximate number of people managed in total (all levels) : 2-6
Education, Qualifications, Skills and Experience
- Bachelor's degree required, with at least 5 years of relevant experience in the biopharmaceutical industry
- Demonstrable experience of analytical diagnostic assay validation and use in a clinical testing setting.
- Broad knowledge of scientific literature with deep understanding in diagnostic biomarker related area demonstrated through publications 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)
- Proven experience of delivery and use 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, through effectively working across internal and external boundaries.
- Ability to communicate with stakeholders for study updates, testing progress through oral presentations and progress reports
- Ability to identify risks and escalate appropriately
Skills & Capabilities
- Good interpersonal skills and ability to act as an ambassador for TM/AZ internally and externally
- Ability to interact successfully with multiple customers across functional boundaries; particularly with clinical/scientific thought leaders
- Ability to work independently, designing, executing and interpreting tasks
- Can identify and address critical issues in the context of strategic direction
- A confident team player who is assertive but willing to listen and learn from the views of others
- 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.