We are seeking a highly motivated Clinical Supply Chain Manager that thrives in a fast‑paced and dynamic environment while working on multidisciplinary teams. The 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.
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.
* Creates, leads, influences, and manages cross‑functional 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
* 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 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.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1‑877‑694‑7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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