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Clinical Supply Chain Manager

We are seeking a highly motivated Clinical Supply Chain Manager that thrives in a fast-paced and dynamic environment while working on multi-disciplinary teams. The Supply Chain Manager (SCM) role provides strategic oversight of the end-to-end supply chain for assigned GSK R&D investigational assets. The SCM is accountable for determining supply strategies that successfully deliver investigational medicines to patients while ensuring the supply chain delivers results that support GSK R&D registration & launch milestones.

The SCM is responsible for influencing clinical plans relative to investigational product (IP) supply and determining optimal supply strategies that are patient-focused, risk-adjusted, and cost effective. Furthermore, the SCM follows through on supply chain performance to ensure the successful execution of the supply chain. This role supports Phase I through IV GSK sponsored clinical studies as well as investigator sponsored trials and compassionate use programs.

  • Leads the cross-functional Clinical Supply Chain Network team and is accountable for the Clinical Supply Workstream as part of the overarching medicines development process.
  • Builds and maintains strong working relationships as the primary interface with Clinical and cross-functional program teams at the program level. 
  • Serves as the first point of escalation for issues related to investigational product supply. 
  • Challenges key assumptions and Clinical planning parameters while influencing clinical study proposals to ensure optimal cost / risk / benefit tradeoffs.
  • Influences partners to ensure that clinical development strategy, planning and execution are aligned with delivery of an efficient supply chain with minimal waste and with an agreed risk profile.
  • Aligns cross-functional supply teams on the challenges, assumptions and constraints of the clinical supply chain and ensures supply options and risks are explored and agreed
  • Influences team decisions to maximize the use of resources/materials, which may be in short supply.
  • Mitigates and manages supply chain risks, ensuring continuity and security of supply while working within the confines of the current regulatory environment.
  • Develops and oversees long-term demand and supply plans that cover the end-to-end supply chain for all assigned GSK assets.
  • Oversees planning for active investigational products, placebos, and comparators.
  • Ensures compliance with the published planning calendar and planning deliverables.
  • Designs and executes supply chain strategies that deliver on the GSK R&D ambition while ensuring consistent on-time delivery of medicines to patients with minimal waste.
  • Leads packing strategy on a program basis, influencing facilities, equipment and sourcing decisions.
  • Determines investigational product blinding strategy.
  • Directs the Supply Chain Study Lead and Planner on setting inventory policies (API to Patient Kit)
  • Monitors supply chain performance to identify, understand, and respond to changes.
  • Maintains up-to-date program plans and supporting documentation.
  • Works with business partners to oversee the effective execution of supply chain plans while proactively identifying potential obstacles to success and taking action to resolve issues.
  • Develops costed, risk-based scenarios for supplies to enable Medicines Development Leaders and Medicine Development Teams to make informed decisions regarding budget allocation.
  • Ensures supply chain planning is aligned with key project milestones and provides input into Integrated Project Team as required.
  • Create, lead, influence and manage cross-functional teams, including external groups, to co-ordinate and manage the delivery of clinical supplies for specified GSK asset(s) at the program level.
  • Creates Study Specific Technical Agreements (or equivalent) for specified projects.
  • Accountable for complex problem solving and resolution of issues involving a range of technical, quality, regulatory and operational issues to ensure delivery to patient without compromising quality or cost.
  • Basic Qualifications:

  • B.S. or M.S., in Pharmacy, Chemistry, Logistics, or related scientific or supply chain discipline.
  • Experience in Upstream and Downstream Clinical Supply Chain processes, planning, and procedures
  • 5+ years of experience working in pharmaceuticals.
  • Experience in the management of clinical trial supplies including, but not limited to planning, forecasting, inventory management, clinical packaging, distribution, and IRT
  • Experience in a matrix leadership or direct leadership role
  • Experience with global supply chain design, logistics, demand, and supply planning of clinical trials.
  • Experience working with global regulatory requirements, including cGMPs, ICH and GCPs.
  • Experience working with senior leadership including but not limited to Clinical Operations, Clinical Supply, and CMC leadership.
  • Project management experience
  • Preferred Qualifications:

  • Understanding of the drug development process and experience with clinical supplies manufacturing and packaging
  • Ability to maintain accurate records and files in accordance with cGMPs and SOPs.
  • Ability to independently perform trouble-shooting and problem-solving. Ability to follow-up and evaluate problems appropriately.
  • Strong leadership, communication and interface management skills, including strong partnership behaviors that enable transparent communications and team alignment. 
  • Demonstrated ability to lead and to influence global cross-functional teams.
  • Must exhibit excellent oral and written communication skills, interpersonal, and influencing skills.
  • Excellent project management skills
  • APICS or CILT certification
  • Lean Sigma training/Experience
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    Clinical Supply Chain Manager

    Company:
    1054 GlaxoSmithKline Services Unlimited
    City:
    Rixensart
    Contract type: 
    Permanent, Full-time
    Categories: 
    Supply Chain Manager, Supply Chain
    Career level: 
    Manager
    Published:
    02.05.2024
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