AstraZeneca is one of the world’s most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world.
The Supply Chain Study Manager (SCSM) role is a key leadership role within R&D Supply Chain. The role holder will manage the supply chain for a portfolio of global clinical studies across all phases within a drug development programme. He / she will lead cross-functional Study Drug Delivery Teams and represent these teams on the R&D Supply Chain Team. The SCSM works in collaboration with customer functions to influence and manage demand for individual studies, and is responsible for their supply chain deliverables through leadership of the Study Drug Delivery Team.
Leads and provides direction to Study Drug Delivery Teams (SDDTs) comprising members of R&D SC, Clinical Development and external partners. Ensures SDDTs operate within boundaries set by Supply Chain Teams. Represents the Study Drug Delivery Team activities for all studies within a programme on the Supply Chain project team.
- Ensures team delivers clinical supplies effectively and consistently, balancing cost and risk to supply.
- Ensures expert input and support from cross functional groups.
- Ensures effective communication within the SC and with customers and SC partners. Establish and lead risk management of individual studies during the planning phase, with proactive mitigation of risks threatening quality or delivery of supplies. Escalate significant issues to SCT as appropriate.
Skills & experience Experience,
- Understands and translates clinical study protocol requirements into demand for drug product within a clinical study including requirements for placebo, comparators and rescue / challenge medication. Author the drug supply section of Clinical Study Protocol and lead development of master label text.
- Use simulation tools and supply chain expertise to design optimised, lean supply chains for individual studies, defining allocation of contingency stock, IVRS parameters and requirements of drug product. Where possible seek innovative flexible supply chain solutions capable of supporting multiple studies.
- Using this information, develop options for how the supply requirements of individual/groups of clinical studies can be delivered and propose to the Supply Chain Team. This will include sourcing (in or out) and alignment of sourcing activities with customers, detailed plans including timing of investments/cost expenditure (e.g. purchase of comparator product, phased spend at CROs), identification and management of risks.
- Produce a Study Drug Packaging Agreement documenting the agreed supply option providing details of the design, set-up and how the supply chain will operate for each study/group of studies.
- Ensure SC input into the design of the random scheme, incl. pack lists and timely provision of these to Delivery or CRO.
- Define IVRS user requirements, set up IVRS tool and ensure timely go-live for individual studies. Use IVRS to track recruitment and adjust IVRS parameters to accommodate any changes in study scope and design
- Collaborate with CRO partners in development of pack design and review the technical part of the outsourcing contract. Review changes to the contract with CRO partners and Sourcing Managers as necessary.
- Establish the supply chain for individual/groups of studies and ensure delivery of the end to end supply of materials to meet study needs.
- Monitor the performance of the supply chain and optimise for higher volume phases of the project, balancing speed, quality and cost with respect to the agreed level of risk.
- Monitor the budget for individual study supply activities and materials for the project. Flag deviations to SC Programme Manager.
- Maintain appropriate information for study supply activities to support updates in OPAL.
- Manage change in demand and supply, resolve issues, escalating when appropriate.
- Work with other Study Managers to resolve issues, share best practice and continually develop competence.
- Promote supply chain practice in Pharm Dev and interfacing functions.
- Where appropriate deputise for SC Programme Manager on SCT and PD Project Team.
- Represent R&D SC at monitors / investigators meetings and share learning within AZ.
Functional Knowledge, Business Knowledge, Education, Specialist Skills:
Skills and Capabilities:
- Degree in supply chain related or drug development discipline or equivalent qualification or experience.
- Previous experience in Pharmaceutical industry
- At least 3 years of working experience in supply chain and/or clinical trials environment
- Significant experience managing and influencing customer demands.
- Knowledge of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products In depth knowledge of R&D supply chain and drug development process.
- Experience of project management.
- Strong influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries.
- Demonstrated technical skills and mindset in supply chain management including demand management, supply chain design / optimisation and delivery.
- Track record of good project management.
- Risk identification and management.
- Excellent written and verbal communication skills. Fluency in English is essential.
- Passion for Customers: Understands one’s customers and uses that insight to provide value.
- Thinks Strategically: Quickly identifies and acts on opportunities, combining forethought with action. This is based on an understanding of the external environment and its impact on AZ.
- Acts Decisively: Makes and acts on decisions quickly and effectively and fosters the same in others. This is based on an underlying courage to enable risk taking for the business.
- Drives Performance: Holds self and others accountable for the achievement of performance expectations. Creates an environment that enables others to perform at their best.
- Works Collaboratively: Actively creates and promotes cross boundary collaboration with the aim of archive better business results. Boundaries can exist between individuals, geographies, cultures, teams, functions or organisations.
- Develops People and Organisation: Demonstrates and genuine commitment to the time and effort needed to develop oneself and others.