Director of Clinical Supply Chain - Externally Sponsored and Access Programmes

AstraZeneca; Macclesfield; On-site; GBP 60,000 - 120,000; Full time

Job description

Director of Clinical Supply Chain - Externally Sponsored and Access Programmes

Macclesfield (UK)

WHY JOIN US

Here our work has a direct impact on patients – transforming our ability to develop life-changing medicines. We empower the business to perform at its peak and lead a new way of working, combining innovative science with leading digital technology platforms and data. All with a passion to impact lives through data, analytics, AI, machine learning and more. Join us at a crucial stage of our journey in becoming a digital and data-led enterprise. Make the impossible possible by building partnerships and ecosystems, crafting new ways of working and driving scale and speed to deliver exponential growth. Focused and committed, and backed with the investment to succeed, we’re driving cross-company change to disrupt the entire industry.

About the Role

The Director Clinical Supply Chain - Externally Sponsored and Access Programs Non-Standard Clinical Supply is a key role within the Oncology Clinical Supply Chain Therapy Area, who is accountable for end-to-end clinical supply chains outside of the core programme management. This includes management of ESR (Externally sponsored research) studies, PTAP (Post-trial access programmes), EAP (Early Access programmes), SiPCU (Single Patient Compassionate use). They will be responsible for setting up a new cross-functional team that will take on the management of these kind of programmes/studies across the Oncology and Biopharma portfolio. They will also act as an SME and Business Process Owner for the area and drive optimisation of current processes/ways of working and be a strong influencer in the design of these supply chain strategies. They will be a key partner to the CSPLs and bridge the connection with key partners within and outside AZ for successful management. They will lead matrix multi-functional international teams to drive strategy and to manage supply chain performance through key performance indicators.

Key Responsibilities

1. Accountable for the development and performance of clinical supply chains for ESR, PTAP, EAP and SiPCU across the oncology and biopharma programmes, owning the E2E supply of products in the development portfolio.
2. Be influential in the design phase with relevant experts to drive optimised design with respect to quality, risk and cost for the business.
3. Supervises the performance of the clinical supply chain and optimises for higher volume phases of the project, balancing speed, quality and cost with respect to the agreed level of risk.
4. Accountable for a significant budget for supply activities and materials for the portfolio.
5. Maintain appropriate information for supply activities in PLANIT on an ongoing basis and in line with RBU.
6. Ensure ongoing supply through transition from development sources to commercial sources of manufacture.
7. Manage change in demand and supply, resolve issues, advancing when appropriate.
8. Understands and acts according to GxP and knows the impact it has on supply chain activities.
9. Ensure timely delivery of information to meet internal and external regulatory and legal requirements.
10. Lead a cross-functional team to resolve issues, share standard methodology and continually develop competence.
11. Promote clinical supply chain practice in PT&D and interfacing functions.
12. Be responsible for introducing innovation into the Supply chain ensuring a culture of continuous improvement is encouraged and managed.
13. Take a lead in inspiring others within the function and communicating the Supply Chain strategies.
14. Take ownership for managing issues and making complex trade-offs with both internal and external partners. This will require well developed conceptual and analytical thinking to make sophisticated judgements and deliver innovative solutions.
15. Act as a sponsor to support and manage the implementation of supply chain change and be the 1st point of contact for Senior Partners within the organizations regarding your portfolio of products.

Essential Skills and Experience

1. Bachelor’s degree (equivalent) or higher.
2. Extensive, proven experience in managing specialized low volume high variability clinical supply chains (ESR, EAP, PTAP, SiPCU) from a strategic perspective.
3. In-depth knowledge of the current processes and ways of working with regards to clinical supplies for ESR, EAP, PTAP, SiPCU.
4. In-depth knowledge of Clinical Development processes relevant to investigational products and its impact on clinical supply chain considerations.
5. Proven entrepreneurial mindset, challenging the status quo to drive simplification and increased productivity from a supply chain and process perspective.
6. Substantial change management experience with regards to both setting up and rolling out new processes and improvement of existing processes.
7. Extensive experience in managing business partner relationships with external parties (both within and outside of AZ).
8. Established network with parties relevant to management of externally sponsored and access programme for clinical supply, such as (but not limited to) GMA, ClinOps and external service providers.
9. Strong project management, communication and influencing skills across geographical and cultural boundaries.
10. Strong stakeholder management capabilities across multiple layers in an organisation (including senior leaders).
11. Extensive experience in budget management and optimisation of clinical supply chains across multiple programmes.
12. Proven strong leadership skills, creating a psychologically safe space to generate high-performing teams.
13. Awareness of GXP Standards within a Clinical environment and its impact on management of non-standard clinical supply.
14. Extensive experience of Clinical demand and supply planning processes with regards to clinical supply of ESR, EAP, PTAP, SiPCU programmes.
15. Solid understanding of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products.
16. Proficient IT skills with an ability to adapt and operate in multiple systems.

Desirable

Line management experience.

ABOUT ASTRAZENECA

AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash 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 NEXT?

If reading the above has tickled your senses and you’re ready to join us, hit the apply button, and we look forward to reviewing your application soon.

Competitive salary & benefits offered.

Date Posted: 09-Apr-2025

Closing Date: 23-Apr-2025

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.

About the company

AstraZeneca PLC is a British-Swedish multinational pharmaceutical and biopharmaceutical company with its global headquarters in Cambridge, England.