Job Description
Clinical Supply is a key role within the Chemistry, Manufacturing, and Controls (CMC) team. You will manage the supply chain for a portfolio of global clinical studies across all phases of development through collaboration with various functions including external CRO’s and CDMO’s. You will get to cover a full spectrum of the clinical study lifespan, across all phases of the drug development lifecycle, covering small molecule drug products. We are #BrighterTogether.
In this role you will:
- Understand and translate clinical study requirements into demand for drug substance and drug product for individual and collective studies for each development
- Using simulation tools and supply chain expertise you will design optimized, lean, supply chains for individual studies, defining allocation of contingency stock.
- Collaborate with Clinical Operations and other internal departments to design and build IRT systems, UAT testing.
- Management of manual clinical supply drug orders.
- Develop supply options for individual/groups of clinical This will include alignment of sourcing activities, detailed plans including timing of investments (e.g. inventory build-up for drug substance and drug product), identification and management of risks.
- Collaboration with internal CMC functions for seamless expiry management at clinical sites and depots.
- Develop the spend forecast for clinical packaging, labelling, and distribution cost.
- Investigational labeling process—from development of master text through translations, review, and proofing.
- Collaborate with CRO partners and Clinical Operations in the development of pack design and review the technical details of the outsourcing contract for clinical supply chain, as well as development of label text for comparators/co-drugs.
- You will be a go-to contact for supplies management with our Clinical Operations
- Provide active management of the clinical supply, providing routine and independent problem Ensure the team delivers clinical supplies effectively and consistently, balancing cost and risk to supply.
- Review and approve documentation related to packaging, labeling, and distribution of clinical Maintain supply chain documentation within eTMFs, as required.
- Make sure the flow of communication with customers and supply chain partners is a smooth
- Own change in demand and supply and helping to resolve
- Track recruitment and adjust supply plans to accommodate changes in study
We are looking for people who:
- Hold a degree in a supply chain/drug development-related discipline or equivalent qualification
- Are able to thrive in a fast-paced environment; resourcefulness, collaboration, flexibility, and self-motivation are key at Constellation.
- Can offer 5+ years’ experience working in a supply chain function
- Believe managing customer requirements is an area where they excel and enjoy spending their time
- Understand the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products
- Are well versed in the area of drug development (especially clinical development) process
- Can demonstrate that leading and managing projects is an area of expertise
- Influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries are all strength
- A strong track record of good project management
- Ability to proactively identify and manage risks
- Excellent written and verbal communication skills
