Position Summary
Create and maintain supply strategies for all investigational product based on the scientific and regulatory confines of the drug’s development with minimal supervision.
Key Responsibilities
* Collaborate with internal Global Clinical Supply Chain (GCSC) teams and external customers and service providers, including Global Drug Development, Pharmaceutical Development, Product Development Quality (PDQ), external vendors and medical teams to ensure all needs are met.
* Proactively define, plan and communicate the clinical supply chain strategy to support global clinical studies and align with study and corporate goals.
* Present at cross‑functional meetings, demonstrating strong knowledge of GCSC processes.
* Identify and support strategies for continuous improvement across departments.
* Influence clinical and development timelines, study design and country selection.
* Review and provide input to draft clinical protocols, communicating timelines and investigational product strategies to study and cross‑functional teams.
* Develop supply forecasts for studies through evaluation of the clinical development plan and protocol analysis.
* Monitor inventory and analyze drug utilization versus forecast taking into account country requirements and logistical timelines.
* Issue Manufacturing and Packaging/Labeling requests to Clinical Supply Operations (CSO) in alignment with RDSC master‑planning timelines and collaborate with Clinical Development, CMC and CSO Packaging and Labeling to meet protocol and regulatory requirements.
* Monitor use dates of investigational drug product for assigned protocols and support use‑date extension activities, including generating UDE memos and coordinating support for UDE labels.
* Ensure timely delivery of quality clinical supplies for all assigned compounds and protocols, collaborating with internal and external sources while considering country regulatory and QP release requirements.
* Participate in development, review and approval of Interactive Response Technology (IRT) specifications.
* Develop investigational product distribution strategies and maintain distribution and supply strategies at depot and site level according to study and IRT requirements.
* Actively participate in internal Trial Supply Management and Clinical Supply Chain meetings, Study Team meetings, Clinical Supply Matrix Team meetings, and other relevant meetings, providing all necessary data and documentation prior to each meeting and highlighting risks and mitigation strategies.
* Collaborate with the Clinical Supply Strategic Sourcing team to procure commercial drug in alignment with country and clinical study requirements, attending vendor meetings and generating purchase requisitions as needed.
* Actively support the budget process by maintaining supply and demand estimates in the Budget Tool and regularly reviewing and updating against revised clinical plans.
* Serve as the main Clinical Supplies contact for the assigned compound and associated studies, leading communications regarding global supply strategy with study teams.
* Support actions stemming from change controls and collaborate with Compliance to prepare eTMF, CSR appendices and batch listings to support inspection readiness activities.
* Enter product complaints and deviations in the appropriate system and work with PDQ for investigation and resolution.
* Manage conflicts and issues with internal and external partners and customers.
* Write departmental procedural documents as applicable.
* Perform other tasks as assigned.
Experience and Knowledge
* Minimum 2 years pharma industry related experience.
* Minimum 1‑year clinical supplies/development experience with global exposure or equivalent.
* Moderate / strong knowledge of the global drug development process and regulatory requirements.
* Proficient and strong analytical skills.
* Strong communication and negotiation skills.
* Proficient and strong project‑management skills.
* Strong knowledge of forecasting and planning and proficiency in related areas such as manufacturing, packaging & labeling, IVRS, logistics, quality, stability, etc.
* Proficient knowledge of import / export requirements.
* Proficient / strong knowledge of IVRS and CTMS systems.
* Proficient / strong knowledge of industry technology.
* Ability to apply and drive forecasting and planning activity as it relates to protocol.
* Ability to build and drive internal team consensus.
* Translate broad strategies into specific objectives and action plans.
* Team and individual leadership; lead courageously.
* Oral and written communication; foster open communication.
* Conflict resolution; manage disagreements.
* Negotiation; manage execution and results.
* Influencing; manage influencing others.
* Coaching and mentoring; foster teamwork.
* Education: BA/BS in Science, IT or Business, preferably with focus on IT, digitization or supply chain.
Equal Employment Opportunity
Bristol Myers Squibb is an equal‑opportunity employer committed to diversity, inclusion and equal rights.
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