Senior Manager, Trial Supply Management

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Senior Manager, Trial Supplies Management

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Role

Bristol Myers Squibb is looking to recruit a permanent Senior Manager, Trial Supply Management.

Global Clinical Supply Chain (CSC) is a new organization within Global Supply Chain (GSC). GSC’s vision is to be a patient-centric, integrated supply chain, launching and supplying innovative products that deliver hope to patients through life-changing medicines. The Global Clinical Supply Chain (CSC) organization contributes to this vision by working seamlessly across the enterprise to supply BMS’s global portfolio of clinical studies. CSC represents an innovative organizational model, an innovation that enables BMS for a future in which commercial supply chains will be increasingly similar to clinical supply chains due to advances in personalized medicine and targeted therapies.

Position Summary

Provides senior-level accountability, oversight, and execution of supply strategies for all investigational products based on the scientific and regulatory confines of the drug’s development with minimal supervision.

Roles and Responsibilities

• Collaborates with internal Global Clinical Supply Chain (GCSC) teams and external Customers and Service Providers, including but not limited to Global Drug Development, Pharmaceutical Development, Product Development Quality (PDQ), External Vendors and Medical to ensure all needs are met.
• Partners with the Clinical Supply Lead (CSL) in planning and communicating the clinical supply chain strategy in support of global clinical studies to ensure optimal use and alignment with study and corporate goals. Demonstrates robust knowledge and confidence of GCSC processes when presenting at cross-functional meetings.
• Formulates and drives strategies for continuous improvement to supply strategies for investigational products, both departmental and/or inter-departmental.
• Influences clinical and development timelines, study design and country selection. Responsible for reviewing and working with the CSL to provide any contributions to the clinical protocol and directly responsible for protocol amendments, communicating timelines and investigational product strategies to study and cross-functional teams.
• Monitors inventory and analyzes drug utilization versus forecast taking into account country requirements and logistical timelines.
• Issues Packaging/Labeling requests to Clinical Supply Operations (CSO) in alignment with RDSC Master Planning timelines and based on collaboration with CSO Packaging and Labeling to ensure package design and clinical label for investigational product meet protocol and regulatory requirements.
• Monitor use date of investigational drug product for assigned protocols. Support use date extension activities, such as generation of Use Date Extension (UDE) memo and provide feedback to Logistics team to support generation of UDE labels for depots and clinical sites.
• Derives enhancements to improve the timely delivery of quality clinical supplies for all assigned compounds and protocols by collaborating with internal and external sources while taking into account global and country Regulatory and QP Release requirements.
• Participates in development, review and approval of Interactive Response Technology (IRT) specifications. Executes investigational product distribution strategies and maintains distribution and supply strategies at depot and site level according to study and IRT requirements.
• Actively participates in internal Clinical Supply Chain meetings, Study Team meetings, Clinical Supply Matrix Team meetings and any other relevant meetings providing all relevant data and documentation prior to each meeting, highlighting any risks and mitigation strategies.
• Collaborates with Clinical Supply Strategic Sourcing team to procure commercial drug in alignment with country and clinical study requirements. Attends meetings with vendors and generates purchase requisitions as needed.
• Supports associated actions stemming from change controls.
• In collaboration with Compliance, prepare eTMF, CSR appendices and batch listings to support inspection readiness activities.
• Manages conflicts/issues with internal and external partners and customers.
• Writing of departmental procedural documents as applicable.
• Performs other tasks as assigned.