Role Summary
Executive Director, Global Clinical Supply Chain (GCSC) leads the clinical planning function within an assigned therapeutic area, acting as an end-to-end leader who inspires teams and drives the overall GCSC strategy. The role provides subject matter expertise across a diverse portfolio of development programs and modalities (small molecules, biologics, cell gene therapy) for Gileadโs global clinical trials. The position collaborates with GCSC and other functions to develop strategies, meet project deliverables, and manage the end-to-end process from protocol design through manufacturing to distribution and inventory management of clinical supplies worldwide.
Responsibilities
- Establish strategies to ensure uninterrupted clinical supply for the development portfolio across all phases and managed access programs, and lead large complex projects within the department.
- Lead, develop, and manage teams including recruitment, onboarding, and succession planning.
- Set clear goals and accountability aligned with department and enterprise objectives; drive a culture of continuous improvement.
- Develop plans cross-functionally within PDM and the enterprise to implement best practices.
- Perform sponsor roles as requested; champion clinical demand and operation planning (CDOP) interfacing with Clinical Operations and PDM sub-teams; manage across enterprise functions to ensure on-time, in-full delivery of IMP.
- Ensure efficient resource allocation for PDM sub-teams and clinical study teams; ensure OTIF delivery of IMP to initiate and resupply clinical studies.
- Direct long-term vision for optimal supply chain strategies including labeling and distribution activities; balance risk and allocate work; drive resolution of complex issues with sponsors as needed.
- Develop SOPs, work instructions, policies, and procedures to ensure GxP compliance; influence cross-functional SOP content and approvals.
- Oversee and support clinical study planners; facilitate issue and risk identification, mitigation, resolution, and communication.
- Serve as PDM sub-team lead for RFD assets and lead supply management for first-in-human trials; drive cross-functional decision-making to support long-term vision.
- Manage departmental budgeting, including forecasts for clinical supply spend, headcount, contractors, consultants, and project expenses; lead TA-level allocation decisions and negotiate partner performance.
Qualifications
- Required: 16+ years of relevant industry experience with BA/BS, or 14+ years with MA/MS or MBA, PhD or PharmD.
- Required: expert working knowledge of clinical supply chain best practices and experience in a GxP environment; strong cross-functional, multi-cultural communication skills; hands-on end-to-end clinical supply experience in oncology with strategic portfolio oversight.
- Preferred: advanced degree (MS, PharmD, MBA) in a science-related field; experience in forecasting, demand/supply planning, IRT systems, inventory management, clinical labeling, distribution (including cold chain), import/export, reverse logistics, CMC and GxP regulations; prior oncology trial experience.
- Required: excellent verbal, written, and interpersonal communication; ability to write clear, concise documents and presentations; confident communicator and presenter to all levels; strong computer, database, and organizational skills; ERP/Planning System experience a plus.
Education
- Bachelorโs degree required; advanced degrees (MS, PharmD, MBA) desirable.