Société : 1054 GlaxoSmithKline Services Unlimited Lieu : Rixensart Wallonia Site source : Talent BE
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 supplychain performance to ensure the successful execution of the supplychain.
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 ClinicalSupplyChain Network team and is accountable for the ClinicalSupply 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 supplychain with minimal waste and with an agreed risk profile.Aligns cross-functional supply teams on the challenges, assumptions and constraints of the clinicalsupplychain and ensures supply options and risks are explored and agreedInfluences team decisions to maximize the use of resources/materials, which may be in short supply.Mitigates and manages supplychain 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 supplychain 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 supplychain 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 SupplyChain Study Lead and Planner on setting inventory policies (API to Patient Kit)Monitors supplychain 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 supplychain 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 supplychain 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 supplychain discipline.Experience in Upstream and Downstream ClinicalSupplyChain processes, planning, and procedures5+ 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 IRTExperience in a matrix leadership or direct leadership roleExperience with global supplychain 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, ClinicalSupply, and CMC leadership.Project management experiencePreferred Qualifications:
Understanding of the drug development process and experience with clinical supplies manufacturing and packagingAbility 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 skillsAPICS or CILT certificationLean Sigma training/Experience#LI-GSK #CMCDevelopmentGSK Please visit to learn more about the comprehensive benefits program GSK offers US employees.
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