Senior Manager, Global Clinical Supply Chain

Senior Manager, Global Clinical Supply Chain

Senior Manager, Global Clinical Supply Chain is a leader who carries out leadership vision and directions while providing expertise for Gilead's global clinical trials. Works collaboratively within the department and with cross functional colleagues (e.g., Regulatory, Clinical Operations, Quality, PDM Product Strategy teams, GSC, Information Technology, etc.) to develop strategies, meet project deliverables, and solve business problems. The position has end-to-end leadership and accountability for clinical supply management.

Prioritizes and creates executable work plans to ensure on time in full, safe delivery of investigational medicinal products (IMP).

The role may have people leadership accountabilities which include recruiting, onboarding, developing, retaining and managing staff.

The role may have accountability for the strategy, implementation and management of digital tools and systems that support Global Clinical Supply Chain. The intent is to bridge gap between supply chain processes and information technology, ensuring the right digital or technology platform is in place to optimize clinical supply planning, inventory management and distribution.

Has mature working knowledge of supply chain and experience working with GxP environment. Has strong cross-functional, multi-cultural awareness and communication skills in a fast-paced, global company.

• Interprets clinical study protocols and/or dosing schema. Translates the information to IMP demand and supply planning requirements, distribution strategies including depot inventory management.
• Performs demand and/or supply forecasting and planning with planning horizon of 9 to 18 months. Translates forecasts into clinical packaging and labeling (CPL) execution plans. Supports contract/quote reviews and purchase order and invoice reconciliations.
• Develops and implements depot and clinical site seeding and resupply strategies.
• Supports the clinical development and PDM strategies working collaboratively within GCSC, Quality and other functional groups to develop clinical supply strategies and plan with the focus on delivering compliant, quality IMP to clinical trials globally on time in full.
• Ensures accurate inventory and records at depots through timely reconciliation.
• Keeps abreast of clinical supply incidents and issues. Reports and escalates issues as well as investigates root cause as appropriate.
• Performs tasks in Gilead systems (e.g., SAP, IVRS, QMS, etc.) to enable compliant and efficient progression of IMP through the supply chain.
• Authors SOPs and business process work instructions as per leadership direction and support.
• Supports regulatory filings and inspections.
• Maintains compliance of clinical supply deliverables for clinical study reports (CSR) and trial master file (TMF).
• Maintains compliance with required training.

• IVRS support: serves as the primary contact of interacting and collaborating with internal and external partners. These include and not limited to Clinical Vendor Outsourcing, Clinical Operations and IVRS vendors. Provides subject matter expertise for the design, development, configuration and user acceptance testing (UAT) as related to IMP management in accordance with clinical study protocol. Provides troubleshooting support for system issues as they arise.
• Enterprise Resource Planning (ERP) support: serves as the business process owner or lead effectively representing GCSC in the design, development, configuration and implementation of system upgrades or cutover to new ERP system. Has good understanding and working knowledge in master data management.
• Data and analytics: oversees the use of digital systems to gather, analyze and automate data visualization related GCSC. Uses data to enable department’s optimization in demand and supply forecasting, inventory management and supply chain visibility. Must have growth and continuous improvement mindset to ideate and drive initiatives that leverage technologies to automate tasks, reduce human errors as well as increase efficiency and effectiveness of clinical supply chain.

• 8+ Years with…