Senior Manager, Global Clinical Supply Chain

Role Summary

Senior Manager, Global Clinical Supply Chain leads end-to-end clinical supply management for Gilead's global clinical trials. They collaborate with Regulatory, Clinical Operations, Quality, PDM Product Strategy, GSC, IT, and other functions to develop strategies, meet project deliverables, and solve business problems. The role carries leadership responsibilities for delivering on-time, in-full, compliant supply of investigational medicinal products (IMP), and may include people leadership duties such as recruiting, onboarding, developing, retaining and managing staff.

Responsibilities

• 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. Translate 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.
• Digital Systems
  • 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.
  • 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.
• People Leader Accountabilities
  • Create inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
  • Develop talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
  • Empower teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

Qualifications

• Required: 8+ Years with BS/BA OR
• Required: 6+ Years with MS/MA or MBA
• Preferred: Bachelor’s degree with 8+ years of industry experience OR Master’s degree with 6+ years of experience OR PhD or PharmD degree with 2+ years of experience.
• Preferred: Degrees in the sciences preferred.
• Preferred: Strong working knowledge in clinical supply management including and not limited to forecasting, demand / supply planning, IVRS and ERP systems.
• Preferred: Strong working knowledge of clinical study designs, blinding practices, global trials, from Phase 1 first in human to late phase.
• Preferred: Strong working knowledge of Clinical Demand and Operations Planning (CDOP).
• Preferred: Experience with managing comparator drugs and other co-meds for clinical studies.
• Preferred: Ability to collaborate, influence and negotiate to work effectively with cross-functional teams and external suppliers to meet clinical development timelines and patient needs.
• Preferred: Works effectively with ambiguity. Ability to devise, assess and implement best options in alignment with Gilead's core values and functional expectations.
• Preferred: Excellent verbal, written, and interpersonal communication skills. Ability to write clear and concise documents/presentations.
• Preferred: Strategic, enterprise thinking with ability to distill complex business problems to technology solutions.
• Preferred: Strong or excellent computer skills (e.g., email, word processing, spreadsheet creation and management, online search, etc.). Ability to efficiently adopt systems and databases used at Gilead.
• Preferred: Ability to manage the cross functional resources and timelines for complex clinical study and programs or initiatives/projects. Project management experience preferred.