Senior Study Design Specialist (Global Clinical Supply)

Senior Study Design Specialist (Global Clinical Supply)

Permanent opportunity

Location: Macclesfield, UK; Gothenberg, Sweden; Warsaw, Poland; Gaithersburg, US

Competitive salary and benefits

Make a meaningful impact on people’s lives with life-changing medicines

Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better – from patients and their families to all of us in society.

Business area

Clinical Manufacturing & Supply is a key group with in Pharmaceutical Technology and Development (PT&D), we are accountable for the supply to patients across all exciting portfolio of clinical trials. Our global Clinical Program Supply Chain team is growing, and we are now looking for a Global Clinical Supply Senior Study Design Specialist to join our team. Maybe this is you?

What you’ll do:

As a Senior Study Design Specialist (SrSDS), you will use your deep knowledge of clinical supply chains & strong analytical skills to lead the development of the drug supply strategy for clinical studies.

These supply chains are complex with typically high variability in demand, long lead times, technical complexity, regulatory constraints and high cost of goods. Our customer expectations are high with a focus on 100% availability of medicine to patients, speed to deliver and at a minimal cost.

This complexity is likely to increase, and customer demands will remain high. You will work closely with our Clinical Supply Chain Leads (CSCL), study design teams in the Science Units and Clinical Study Supply Leads to optimize the study drug supply strategy.

Your accountabilities will include:

  • Partner with customers with in the AstraZeneca Study Design Process to influence Study Design

  • Actively build relationships across the broader study design team to collaborate effectively.

  • Develop the study design business process by owning a strategic area and drive the CT-Fast system strategy

  • Work closely with Clinical Supply Planning Leads (CSPL) to see opportunities for optimization and provide data driven cost & risk scenarios as part of the Study Design process

  • Develop study supply strategies (kit design, manufacturing strategy, distribution strategy) for agreement with CSPL to provide a baseline for the study supply delivery

  • Ensure Supply Chain levers and considerations are inputted to protocol development and feasibility.

  • Provide on-going support to CSSL to review & redesign the Study Supply Strategy in response to design and operational changes

  • Be a super user & technical expert for the N-side Suite, providing coaching and training for Global Clinical Supply Chain

  • Develop tools & guidance for Global Clinic Supply Chain in study drug supply optimization

  • Mentor & coach other Study Design Specialists

Required Skills:

  • Degree in supply chain related or drug development subject area or equivalent qualification or experience

  • In depth knowledge of R&D supply chain and drug development processes

  • Strong leadership capability, with a proven track record of delivering though others

  • Demonstration of business impact through driving innovation & change

  • Knowledge of pharmaceutical production, supply chain principles, good manufacturing practice, Food and Drug Administration requirements (or equivalent) and Customs rules and regulations

Desirable skills

  • Demonstrated technical skills and approach in supply chain management including demand management and supply chain design / optimization

  • Experience of supply chain optimization tools (eg N-side Suite/CT-Fast or equivalent)

  • Strong understanding of the principles of risk

Why AstraZeneca…

As a global business in stable growth there are long-term opportunities and multiple pathways to take, from setting up systems and processes to developing technical skills and knowledge. And we do it with a real sense of team spirit, pushing and encouraging each other to achieve our best!

Next steps…

We welcome your application by 25th November 2021!

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