Role: Associate Director Clinical Supply IRT
Role Type: Temporary – 12 Months
Location: Remote (with ad-hoc attendance on-site in Macclesfield)
Your New Company & Role
The Global Clinical Supply Chain function is accountable for the supply of medicines to AstraZeneca’s clinical trials. The use of IRT technology allow 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.
Accountabilities / Responsibilities
This document defines all responsibilities as Associate Director Clinical Supply IRT could undertake – the responsibilities to be performed in a calendar year will be identified in the goals and objectives for that year.
The Associate Director Clinical Supply IRT is accountable for delivering the GCSC inputs to the onboarding and Continuous Improvement of IRT Standards and studies which can include but is not limited to:
- Inputting to and completing Technical Standards documentation both standards and studies
- Completing Risk Assessment both standards and studies
- Develop and deliver training material on standards
- Create internal SOP’s to document and define process
- Represent Global Clinical Supply Chain in governance interactions, both internal and external
The Associate Director Clinical Supply IRT will act as a role model and expert 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 – individuals performing this role will be classified as trainers
- 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 setup and change management, and associated values and behaviours and develops excellence in others through their interactions with them.
The Associate Director Clinical Supply IRT is also accountable for the leading projects to develop future solutions and to innovate to meet the challenges of the future supply chain, for example, Direct to Patient in IRT projects, JIT, pooling or other novel innovations.
This role will impact the speed, quality, cost and risk profile of development projects and the overall portfolio and impact the availability of study drug to patients. As such, it has potential to significantly impact the financial and reputational dimensions.
Essential Skills
- In depth knowledge of R&D Supply Chain and drug development process.
- In depth knowledge of Clinical Development processes relevant to investigational products.
- 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 of GMP and GCP
- Risk identification and management
- Excellent written and verbal communication skills
WHY ASTRAZENECA?
It’s an exciting time to join AstraZeneca, a global business that’s rapidly growing – there’s a lot happening and even more to come. And we are a valued part of this journey. Respected partners across the business, we provide the platform that’s going to power us to achieve more.
So, what’s next?
Are you ready to bring new insights and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours. Please apply with a copy of your CV.
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