Executive Director, Global Clinical Supply Chain - Oncology

Role Summary

Executive Director, Global Clinical Supply Chain (GCSC) – Oncology, responsible for leading the clinical planning function within the assigned therapeutic area. An end-to-end leader who inspires teams and drives the overall strategy for global clinical trial supply, including coordination across Development Operations, Clinical Operations, and Process Development and Manufacturing to ensure on-time, in-full distribution of clinical supplies worldwide.

Responsibilities

• Establish strategies to ensure uninterrupted clinical supply for the overall development portfolio across all phases and managed access programs.
• Lead, develop, and manage teams including recruitment, onboarding, and succession planning.
• Set clear goals aligned with department and enterprise objectives; drive continuous improvement across PDM and enterprise functions.
• Foster sponsor roles as requested and champion clinical demand and operation planning (CD&OP) with Clinical Operations and PDM sub-teams to ensure on-time in-full delivery of IMP.
• Ensure efficient resource allocation for PDM sub-teams and clinical study teams; coordinate with enterprise functions to initiate and resupply clinical studies.
• Direct long-term vision for optimal supply chain strategies, including labeling and distribution activities; balance risks and drive resolution of complex issues.
• Develop and implement SOPs, Work Instructions, policies, and procedures to ensure GxP compliance; influence cross-functional SOP content.
• Oversee clinical study planners, facilitate issue/risk identification and resolution, and support RFD asset management for FIH trials.
• Drive cross-functional decision-making to support the departmental and portfolio vision; manage budgeting for clinical supply spends and headcount planning.
• Lead allocation decisions at the TA level and negotiate partner performance with internal and external stakeholders.

Qualifications

• Required: 16+ years of relevant industry experience with BA/BS; or 14+ years with MA/MS or MBA/PhD or PharmD. Expert working knowledge of clinical supply chain best practices and GxP environments. Strong cross-functional, multicultural communication skills suitable for a fast-paced, global company. Hands-on end-to-end clinical supply experience in oncology with strategic oversight at the portfolio level.
• Preferred: Degree in a science-related field; MS, PharmD, or MBA desirable. Experience in forecasting, demand/supply planning, IRT systems, inventory management, clinical labeling, cold chain distribution, regulatory compliance (CMC, GXP), and complex oncology trials. Proven collaboration, negotiation, and relationship-building skills with internal and external stakeholders. Experience with clinical blinding practices in global studies (Phase 1–Late Phase) and sourcing/comparator drug management. Deep knowledge of FDA GxP standards and regulatory guidance (CFR, Annex 13, EU CTR). Ability to lead through ambiguity and communicate effectively at all organizational levels. Proficiency in ERP, planning systems, and project management; strong resource and timeline management across multiple studies.

Skills

• Strong verbal, written, and interpersonal communication; ability to write clear, concise, error-free documents and presentations.
• Excellent cross-functional collaboration, influence, and negotiation capabilities.
• Advanced problem solving, decision-making, and strategic thinking in a complex global environment.
• Proficiency with clinical supply management tools, ERP systems, and planning software.

Education

• MS, PharmD, or MBA desirable (for preferred qualifications).