Project Manager

Translational Medicine supports 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.

In early oncology studies Translational medicine are responsible for the biomarker strategy and implementation which includes all exploratory analyses of clinical trial samples and prospective testing for trial recruitment where required.

The role holder will independently workclosely with the Translational Medicine Leader and diagnostic vendors to oversee the transfer of clinical trial assays as well as to deploy the assays for biomarker testing in early oncology programs with quality and timelinessThe role holder will support TM operation activities in a clinical team, including TM related lab management, sample, data and budget monitoring during clinical study execution.

The role holder is accountable for ensuring that all activities are delivered demonstrating behaviors 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

• Working with TML scientists who have determined study program translational strategy and execution plan for clinical studies in China, the candidate will lead the delivery and execution of the biomarker plans on time and on budget, including but not limited to external vendors for specific clinical programs, supporting China TM contracts, but also managing quality delivery for long-term alliances with customized assay and data delivery to AZ standards and formats;
• Work effectively with procurement to contract the biomarker operations to deliver fit-for purpose laboratory testing from sample receipt to delivery of results, compliant with clinical sample testing guidelines where necessary. Ensure biomarker plan commits CROs/laboratories to deliver timely, fit for purpose testing with sufficient clarity on input for the clinical team to develop site requirements and contracts for sample logistics.
• Work closely with TMLs to assure timely delivery of exploratory HGR approvals, amendment, summary reports; Ensure HGR compliance by tracking study-related approvals, assure compliance of on-going and legacy studies, sample management.
• Lead the creation and maintenance of study documents such as communication, quality management and issue escalation plans, and contribute to team guidelines of such documents;
• Manage clinical samples shipment to testing laboratories and data receipt, compliant with all internal and external regulations. Review and approve sample instructions for clinical sites when necessary;
• Monitor biomarker data quality and timeliness via agreed QC plan; Be accountable for the time, cost and quality of agreed deliverables.
• Monitor and ensure compliance with all AstraZeneca Policies and Standards, HGR regulations and China biosafetey laws, and address instances of non-compliance.
• Support the training of new team members on the standard process of TM operational lead; share TMOPL knowledge and common practices also externally to key stakeholders such as BPLs and GSAMs especially in China-led strategic programs related to TMOP roles to assure quality study delivery.

Education, Qualifications, Skills and Experience

Essential

• Bachelor's degree required, with at least 7 years of relevant experience in the biopharmaceutical industry with > 2 years in translational medicine research program management hands-on experiences in pharmaceutical company
• Demonstrable experience of analytical diagnostic assays, such as immunohistochemistry assays, validation processes and requirements, crucial timeline deterrents and application in registrational clinical trial setting.
• Experiences of working with key central labs in China, independently managing study start-up, biomarker-related database set up and data transfer process.
• Working with scientists to support routine exploratory application for Human Genetic Resource regulations and fluency in application, amendment and submission processes.
• Knowledge of clinical testing procedures and applicable laboratory testing regulations such as Good Clinical Practice, CAP/CLIA, Good Clinical Practice and Quality Systems Regulation)
• Experience of working with testing partners to drive timely and successful outcomes, through effectively working across internal and external boundaries.
• Understanding of key translational medicine deliverables within clinical study,  with the 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
• Ability to work independently, 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

【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.