Typical Accountabilities

• Responsible for establishing study and trial level V2V process. Establish cell therapy site qualification criteria and conduct technical on-site assessment. Responsible for developing V2V related study and trial documents, creating apheresis and product administration manuals and forms and ensure documents are product specific and consistent across all active trials.
• Responsible for providing training to site staff and AZ study team members. Coordinate with internal teams and cell therapy site staff to ensure all site onboarding activities are successfully completed and sites are prepared to support within the required timelines. Manage rollout of process changes.
• Support day-to-day operations of cell therapy trials, e.g., scheduling, communication with involved parties, logistics management, etc., and lead issue solving related to V2V process. Conduct planned quality check on established V2V process of ongoing trials. Support clinical site staff by participating in deviation activities and impact/investigation assessments.
• Work with Quality Assurance and other internal team members (e.g., clinical team, etc.) to monitor and assess vendor performance and capacity.
• Develop, maintain, and evaluate key performance indicators (KPI) for patient treatment execution. Monitor progression of KPIs, identify potential risks, conduct necessary investigation, lead required actions, escalation, and manage communication with relevant stakeholders.
• May take other cell therapy V2V process related activities, assigned by line manager, such as creating V2V process related documents, maintaining relationship with key site staff, etc..

Education, Qualifications, Skills and Experience

Essential

• Bachelor degree or above  in healthcare related discipline or equivalent.
• At least 6 years experience in biotech company or has experience in multinational healthcare industry. Solid experience in Cell Therapy, preferably in clinical development and operations.
• Knowledge of applicable regulations and standards.
• Demonstrated project management skills.
• Fluent in both spoken and written English.
• Able to analyse complexity and solve problems.
• Demonstrated strategic and critical thinking abilities
• Ability to look for and champion more efficient and effective methods/processes of delivering quality result.
• Ability to set and manage priorities, resources, performance targets and project initiatives in a global environment.

Desirable

• Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programs.
• Prior customer facing role in pharmaceutical/biotech industry.
• Experience working with critical raw material suppliers or contract manufacturing organizations.

Key stakeholders and relationships

Internal (to AZ or team)

• Study Teams, Country study team and CRAs.
• Global team members from cell therapy unit.
• Regulatory Affairs
• Patient Safety
• QA and Compliance
• R&D cross functions
• Procurement Department

External (to AZ)

• Clinical site staff and CRCs.
• Staff from cell therapy product manufacture and logistic vendors.
• Regulatory Authorities
• Professional associations and societies
• Academic institutions
• Peer/Industry Groups & Associations

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.