Clinical Supply Study Lead

Cheshire East
Full time
Posted
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AstraZeneca UK
Healthcare & medical
10,001+ employees
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Role Name: Clinical Study Supply Lead

Location: Macclesfield- UK

Competitive Benefits & Salary

Make a positive impact, in a team where it means more

In Operations, we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership, and a clear plan to get there, we bring personal dedication and out of the box thinking.

We are driven by our dedication to deliver accelerated growth for AstraZeneca and to make people’s lives better. It pushes us to keep building on our foundations and progressing as we turn our ever-growing and increasingly sophisticated pipeline from molecule to medicine. Be part of evolving how we work with Lean, ground breaking science, digitalisation and balanced practices.

We have exciting opportunities for Clinical Study Supply Leads (CSSLs) to join our team! The CSSL is a key role within our Clinical Manufacturing and Supply teams. Based at our Macclesfield site, this role involves planning and project managing a portfolio of studies across all phases of a drug development programme ensuring on time delivery to patients.

This position is placed within Pharmaceutical Technology and Development (PT&D), the bridge that turns brilliant science into actual medicines that help millions of people.

The CSSL plans and executes supply chain for one or more global clinical studies across all phases within drug development. The CSSL holds overall accountability for delivery of Intellectual Property and co-ordinates associated tasks and activities across all relevant functions within the supply chain. The Role will have multiple contacts across internal and external groups including leadership of working groups.

What you'll do

  • Plan and Project manage the packaging, labelling and delivery of clinical supplies effectively and consistently, and input to the balance of costs and any risks to supply, following defined business processes

  • Lead the Study Drug Working Group and contribute to the Supply Chain Team Meetings enabling continuous cross-functional dialogue with both internal and external partners on study design requirements and associated changes which may impact the supply chain elements of the study

  • Work within GMP Quality Management Systems ensuring that you actively handle any deviations, complaints and change controls

  • Understand customer demand requirements and have the ability to forecast and translate this into a supply plan

  • Manage the Interactive Response Technology (IRT) system to execute demand and supply planning

  • Take ownership for Inventory management, utilising systems such as Smart Supplies, including any rework and recalls, extensions of shelf life and expiry date management, or stock destruction, supporting waste reduction.

  • Ensure effective communication with project teams and key partners across a global network

  • Support risk management of individual studies with proactive mitigation of risks that potentially impact the quality or delivery of supplies, ensuring consistent on time delivery of drug to patient

  • Supervise the budget for your individual study supply activities and materials for the project including packaging, labelling and distribution costs

Required Skills & Knowledge

  • Bachelor’s degree in a scientific or business subject area – equivalent experience will be considered

  • Experience within a supply chain environment or pharmaceutical industry

  • Holistic knowledge of end to end supply chain activities with proven track record of successful demand and supply planning

  • Experience in running projects and influencing customer demands

  • Analytical aptitude, showing strong data analysis skill base and ability to utilise dashboards

  • Strong influencing, negotiating and problem-solving skills, across geographical and cultural boundaries

  • Risk identification and management

  • LEAN capabilities

  • Proficient IT skills with an ability to adapt and operate in specific multiple systems

Desirable Skills & Knowledge

  • Awareness of GMP (Good Manufacturing Practise) and GCP (Good Clinical Practice)

  • Knowledge of clinical development processes relevant to the supply of clinical materials

  • Experienced in handling Quality Events (Deviations, Change Controls, Complaints)

  • Use of either Smart-Supplies or other sophisticated planning tools and applications would be an advantage

At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and fuel your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

So what's next?

Apply today! Please include your CV and a Cover Letter in your application.

Date Posted

17-May-2024

Closing Date

02-Jun-2024Our 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.