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The role holder will manage the supply
chain for a portfolio of global clinical studies across all phases within a
drug development programme. This role 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.
Role
& Responsibility
· 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
with customers and partners. Establish
and lead supply risk of individual studies during the planning phase, with
proactive mitigation of risks threatening quality or delivery of supplies. Escalate
significant issues as appropriate.
· 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.
· Develop options for how the
supply requirements of individual/groups of clinical studies can be delivered
and propose to the project 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 with vendors 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 supply chain input into the design of the random scheme, incl.
pack lists and timely provision of these to Delivery or CRO.
· 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.
· Understands GMP (Good
Manufacturing Practise) and the impact it has on supply chain activities.
· Monitor the budget for
individual study supply activities and materials for the project.
· Maintain appropriate
information related to study supply activities
· Manage change in demand and
supply, resolve issues, escalating when appropriate.
· Proactively manage study close
out activities, including stock destruction and archiving.
· Work with other Study Managers
to resolve issues, share best practice and continually develop competence.
Education, Qualifications, Skills and
Experience Skills
• Degree in supply chain related
or drug development discipline or equivalent qualification or experience.
• Experience of demand planning
and forecasting
• A significant background in
project managing and influencing customer demands
• Awareness of GMP ( Good
Manufacturing Practise)
• Strong influencing, negotiating
and problem-solving skills, across geographical and cultural boundaries
• Risk identification and
management
• Excellent English written and
verbal communication skills
Preferred
• Extensive experience of
managing supply chain activities and demand planning
• Working 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.
• In depth knowledge of Clinical
Development processes relevant to the supply of clinical materials.
• Experience of project
management.
The R&D (Research and Development) team of Dizal Pharma was AstraZeneca Asia and Emerging Market Research Center. As one of AstraZeneca’s first four R&D centers across the world, it dedicated to analyze the potential scientific mechanism of those most common diseases in Asia and fulfill the particular medical needs of Asian patients. It was one of the few R&D centers established by transnational pharmacy enterprises in China which had the ability to actually research, develop and produce micro-molecular new drugs, the ability to develop produce new drugs independently and completely, and the first-class medical platform in the world.
迪哲医药,于2017年10月独立运营,是一家研发驱动型生物医药企业,致力于全球创新药物(First-in-class/ Best-in-class)探索、研发以及商业化。
迪哲医药的前身为阿斯利康亚洲及新兴市场创新研发中心,设立于中国上海,是阿斯利康全球四个研发中心之一(另三个中心分别位于英国剑桥、瑞典哥德堡、美国盖瑟斯堡);是国际一流、高产出的创新药研发机构,拥有全球领先的转化医学和新药分子设计与筛选技术平台;在恶性肿瘤、自身免疫性疾病、肾病等重大疾病的新药研究方面积累了丰富经验。