Senior 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.

Translational medicine scientific operation program managers are key players for  implementation of translation research strategies which includes clinical assay set up in local laboratories for trial recruitment in early oncology programs, supporting testing and analyses of clinical trial samples.

The role holder will also work closely with the clinical study team to implement the selected options, monitoring ongoing activities to ensure quality of data output.

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

• Support the delivery and execution of the biomarker plan for clinical studies, ensuring that is based on translational strategy led by translational medicine leader working closely with the clinical team and other supporting functions.
• Manage a team of TM scientific PMs to support TM China TMLs in delivery of AstraZeneca portfolio. Conceive and spearhead efforts to improve processes within TM China and enhance project management. Standardize study related information management by working with data platform experts.
• Provide leadership and mentoring for team members; responsible for developing the expertise of team members. Grow team capabilities to support TM activities outside China, such as in a China-led global program.
• Manage external alliance, support China TM activities including assay transfer, vendor evaluation and collaborations;
• 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 clinical testing; Lead the creation and maintenance of study documents such as communication, quality management and issue escalation plans.
• Ensure HGR compliance by supporting HGR application, tracking study-related approvals, assure compliance of on-going and legacy studies, sample management.
• 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 biosafety laws, and address instances of non-compliance. 
• Set a positive and motivating work environment that encourages mutual respect, innovation and accountability at all levels. Balance multiple priorities in a fast-paced, team-based environment and set priorities for self and reports per department needs.

Education, Qualifications, Skills and Experience

Essential

• Bachelor's degree required, with at least 9 years of relevant experience in the biopharmaceutical industry
• Demonstrable experience of analytical diagnostic assay validation and use in a clinical testing setting.
• Demonstrate program management skills with 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.
• Ability to communicate with stakeholders for project 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 effectively communicate and interact successfully with multiple customers across functional boundaries
• A confident team player who is assertive but willing to listen and learn from the views of others
• Excellent organisational skills, with the proven ability to deliver high quality work under pressure and against tight timelines

Desirable

• Masters / PhD or equivalent experience in a relevant subject
• Experience working in early and late phase projects esp on AZ portfolio
• Understandings and hands-on experiences for Human Genetic Resource regulations and previous experiences in application, amendment and submission processes.

【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.