Role Description
This is an exciting opportunity for a highly motivated
Associate Director, Clinical Supply Chain
with a strong background in global clinical supply chain. We are looking for a talented and enthusiastic individual who thrives in a collaborative, fast-paced, and growing environment to join our team.
Responsibilities:
• Clinical Supply Chain Strategy & Management:
• Support the development and execution of clinical supply strategies for planning, sourcing, and distribution to enable global clinical studies.
• Assist in sourcing commercial comparators, including due diligence support, documentation, vendor coordination, and ensuring compliance with country-specific sourcing regulations.
• Collaborate closely with the SVP, CMC, clinical development, and operations teams to align on supply needs, timelines, and resource requirements.
• Contribute to managing the end-to-end clinical supply chain process—from forecasting to delivery at clinical sites—ensuring compliance with protocols, international regulations, and trial timelines.
• Inventory Management & Forecasting:
• Develop and maintain forecasting models for clinical trial materials based on protocols, enrollment projections, and country-specific factors.
• Lead IRT system setup, user acceptance testing (UAT), configuration, and ongoing maintenance for supply tracking and visibility.
• Monitor inventory levels, expiry dates, and batch traceability to maintain appropriate stock at sites and depots while minimizing waste.
• Identify potential supply risks and implement mitigation plans to avoid trial disruptions.
• Support resolution of supply chain issues impacting timelines and ensure continuity of supply.
• Assist in managing clinical supply budgets through cost-effective sourcing and distribution practices.
• Oversee drug accountability, returns, reconciliation, and destruction per GxP and SOP requirements.
• Regulatory Compliance & Quality Assurance:
• Ensure all clinical supply activities comply with cGMP, GDP, and relevant global/country-specific regulations.
• Support quality processes for packaging, labeling, and distribution to maintain product integrity and regulatory standards.
• Partner with Quality Assurance to address deviations, temperature excursions, compliance issues, and audit preparation.
• Stakeholder Communication & Cross-functional Collaboration:
• Act as a primary point of contact for clinical supply matters with internal stakeholders.
• Work collaboratively with clinical operations, regulatory, manufacturing, and other teams to align supply plans with trial needs.
• Provide regular status updates to senior leadership (including the SVP, CMC) on inventory, supply activities, and emerging risks.
• Vendor and Contract Management:
• Manage day-to-day relationships with external vendors (e.g., manufacturers, packagers, logistics providers) to ensure compliant and on-time delivery.
• Support vendor selection, qualification, and performance monitoring.
• Ensure vendor activities meet GMP and regulatory standards.
• Assist in contract negotiation support and adherence to performance metrics and timelines.
• Continuous Improvement:
• Contribute to process enhancements in clinical supply chain operations by implementing best practices and driving efficiency gains.
Qualifications
• Bachelor's degree in Supply Chain Management, Life Sciences, or related field (Master’s preferred).
• Minimum of 7-10 years of experience in clinical supply chain management or a related field, with at least 2-4 years in a leadership or senior role.
• In-depth knowledge of clinical trial operations, cGMP/GDP regulations, and global clinical supply chain best practices.
Requirements
• Strong negotiation, vendor management, and contract coordination skills.
• Outstanding communication, interpersonal, and leadership skills.
• Proven cross-functional collaboration and ability to manage multiple priorities in a fast-paced environment.
• Analytical mindset for forecasting, risk management, and inventory optimization.
Benefits
• Occasional travel may be required, both domestic and international.
• Work Environment: Remote Position
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