Site Name: USA - North Carolina - Zebulon, Belgium-Rixensart, UK - Hertfordshire - Ware RD, USA - Pennsylvania - Upper Providence
Posted Date: Apr 15 2024
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.
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This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- 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.
We are looking for professionals with these required skills to achieve our goals:
- 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
If you have the following characteristics, it would be a plus:
- 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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Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.
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