Clinical Supply Chain Manager

Role Summary

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. This role supports Phase I through IV GSK sponsored clinical studies as well as investigator sponsored trials and compassionate use programs.

Responsibilities

• 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.

Qualifications

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

Skills

• 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 troubleshooting 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.
• Excellent oral and written communication skills, interpersonal, and influencing skills.
• Excellent project management skills.
• APICS or CILT certification.
• Lean Sigma training/Experience.

Education

• Not specified beyond the above degree requirements.