Associate Director Clinical Supply IRT in Macclesfield

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.

The Global Clinical Supply Chain function is accountable for the supply of medicines to AstraZeneca’s clinical trials. The use of IRT technology allows automated inventory management to maintain the right kits, for the right patients, at the right time, in the right place. For each study, Clinical Operations and Global Clinical Supply Chain collaborate closely to build specific IRT requirements which are then configured and validated by the IRT vendor.

IRT is a critical and strategic business application that directly impacts the speed, quality and cost of AZ’s clinical studies. Frequently, configuration/validation activities are on the critical path for study start-up.

• The role is accountable for delivering the GCSC inputs to the onboarding and Continuous Improvement of IRT Standards and studies which can include:
• Inputting to and completing Technical Standards documentation both standards and studies
• Completing Risk Assessment both standards and studies
• Author/approve test scripts as required – both standards and studies
• Develop and deliver training material on standards
• Create internal SOPs to document and define process
• Represent Global Clinical Supply Chain in governance interactions, both internal and external
• The role will act as a role model and consultant to IRT Specialists and within both GCSC and Clinical Operations, which involves:
• Delivery of training and onboarding support for IRT Specialists & mentoring of new team members
• Leading development and process activities within the team and across teams, such as knowledge sharing activities and information sessions
• Consultancy to internal and external groups for both study solutions and process development, as well as assessing programme strategy and proposing solutions to meet programme needs
• Process owner for IRT processes/sub processes
• Drives and role models excellence in delivery in IRT Set up and change management and associated values and behaviours and develops excellence in others through their interactions with them.

• University degree or equivalent qualification in relevant field
• In depth knowledge of R&D Supply Chain and drug development process.
• Deep knowledge of Clinical Development processes relevant to investigational products.
• Demonstrated hands-on experience configuring or operating Interactive Response Technology (IRT) for clinical trials, including translating supply chain designs into IRT specifications and user requirements.
• Track record of creating, maintaining, and improving SOPs, work instructions, templates, and training materials related to IRT and clinical supply processes.
• Practical experience with one or more IRT platforms
• In depth knowledge of IRT systems and interactions
• Proficient IT skills with an ability to understand, adapt and operate in multiple systems.
• Strong influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries.
• Awareness and understanding of GMP and GCP
• Risk identification and management experience.

In Office Requirement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility.

Competitive salary and benefits package on offer! The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, a performance recognition scheme and a competitive, generous remuneration package.

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.