Supply Chain Lead Associate

A global clinical supply organization supporting Phase 1 to Phase 4 clinical trials is seeking a Supply Chain Lead Associate to ensure the timely and compliant delivery of investigational products for clinical trials across all development phases. By developing and executing global supply strategies, this role ensures that studies are supported with the right materials at the right time, while balancing cost, risk, and regulatory requirements.

The Clinical Supply and Strategy Management (CSSM) function is responsible for the strategic planning and operational execution of clinical trial supply. This team designs and delivers investigational product supply strategies across all phases of clinical development (Phase I–IV), ensuring alignment with regulatory requirements, study protocols, and patient needs.

CSSM works closely with internal stakeholders and external partners to manage supply risks, optimize timelines and costs, and support the successful global execution of clinical trials.

Key Responsibilities

• Develop and execute global investigational product supply strategies for clinical studies.
• Act as the primary point of contact for clinical supply planning and execution, partnering with cross-functional teams and external vendors.
• Design clinical supply chain strategies that support study timelines, regulatory compliance, and patient safety.
• Lead multidisciplinary matrix teams to achieve critical clinical study milestones.
• Ensure supply plans are aligned with clinical protocols and operational requirements.
• Proactively assess and respond to changes in study design, such as country participation, site expansion, or enrollment adjustments.
• Identify potential supply chain risks and implement mitigation and contingency plans.
• Manage clinical trial supply budgets, including forecasting and financial communication.
• Maintain accurate and up-to-date project data within supply chain and tracking systems.
• Ensure adherence to applicable quality, regulatory, and compliance standards.
• Represent the clinical supply function during audits and inspections.
• Participate in continuous improvement initiatives and short-term, cross-functional teams.
• Collaborate with global stakeholders and attend meetings across time zones as needed.

This position contributes to organizational success by:

• Enabling efficient clinical supply planning through proactive risk identification and mitigation.
• Driving operational excellence across the end-to-end clinical supply chain, from API sourcing to delivery at clinical sites.
• Influencing study design through innovative packaging, labeling, and distribution approaches.
• Leading cross-functional, matrix-based teams to align supply strategies with program objectives and regulatory expectations.

Ultimately, the Supply Chain Lead Associate supports patients' access to investigational treatments by ensuring reliable and compliant clinical supply execution.

Qualifications

• Bachelor's degree with a minimum of 5 years of relevant experience; or master's degree with at least 3 years of relevant experience; or PhD with relevant experience; or associate's degree with 8 years of relevant experience; or high school diploma (or equivalent) with 10 years of relevant experience.
• Academic background in supply chain, scientific disciplines, project management, or business administration.
• At least 5 years of experience in pharmaceutical or biotechnology project management and cross-functional team leadership.
• Solid understanding of pharmaceutical quality systems and regulatory frameworks.
• Proven ability to operate effectively within matrix organizations, demonstrating strong collaboration and accountability.
• Excellent written and verbal communication skills in English.
• Proficiency with Microsoft Office tools, including MS Project and Office Timeline Pro.
• Availability to work with global teams across multiple time zones.
• Knowledge of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and applicable regulatory standards.
• Experience managing complex clinical development programs and multiple concurrent studies.
• Background in drug development or clinical trial logistics, including areas such as randomization, packaging, labeling, and distribution.
• Strong budgeting, forecasting, and supply demand planning capabilities.
• Ability to align stakeholders, negotiate effectively, and measure performance outcomes.
• Experience delivering presentations to large audiences or participating in industry forums.