Clinical Supply Chain Manager - Rixensart, België - GSK
Beschrijving
Site Name:
USA - North Carolina - Zebulon, Belgium-Rixensart, Upper Providence, Ware RD
Posted Date:
Aug 1 2023
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.
Why You?
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.
This role supports Phase I through IV GSK sponsored clinical studies as well as investigator sponsored trials and compassionate use programs.
- This role will provide YOU the opportunity to lead key activities to progress YOUR career.
These responsibilities include some of the following:
_
Key Responsibilities:
- Leads the crossfunctional 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 crossfunctional 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 mínimal waste and with an agreed risk profile.
- Aligns crossfunctional 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 longterm demand and supply plans that cover the endtoend 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 ontime delivery of medicines to patients with mínimal 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 uptodate 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, riskbased 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 crossfunctional teams, including external groups, to coordinate 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:
- We are looking for professionals with these required skills to achieve our goals:_
- B.S., M.S., in Pharmacy, Chemistry, Logistics, or related scientific or supply chain discipline or equivalent experience in relevant field
- Knowledge in the management of clinical trial supplies including, but not limited to planning, forecasting, inventory management, clinical packaging, distribution, and IRT.
Preferred Qualifications:
- If you have the following characteristics, it would be a plus_:_
- Understanding of investigational product supply requirements for international stud
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