Senior Clinical Supply Manager

Role Summary

We are seeking a detail-oriented and experienced Senior Clinical Supply Manager to oversee the planning, coordination, and distribution of clinical trial materials. The Senior Clinical Supply Manager will ensure that investigational medicinal products (IMP) and other clinical supplies are delivered on time, in compliance with regulatory requirements, and aligned with study needs.

Responsibilities

• Develop and execute clinical supply plans for multiple studies, ensuring timely availability of investigational medicinal products (IMP) and materials.
• Forecast supply needs and manage inventory levels to prevent shortages or overages.
• Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs, and Quality Assurance to align supply strategies with trial requirements.
• Work with packaging vendors to coordinate production, labeling, packaging, and distribution of clinical trial materials.
• Monitor shipment logistics, including temperature-controlled storage and transport, ensuring compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
• Maintain accurate documentation of supply chain activities, ensuring adherence to regulatory guidelines (e.g., FDA, EMA, ICH, GCP).
• Support Investigational Medicinal Product (IMP) release, reconciliation, and destruction processes.
• Identify and mitigate risks associated with supply chain disruptions.
• Optimize supply chain processes by implementing best practices and continuous improvement initiatives.

Qualifications

• Bachelor's degree in a related field (e.g., Supply Chain Management, Life Sciences, Pharmacy, or Business)
• 8+ years of experience in clinical supply chain management within the pharmaceutical or biotechnology industry, familiarity with global clinical trial regulations and international supply chain challenges.
• Strong understanding of clinical trial operations, regulatory requirements, and GMP/GCP/GDP guidelines.
• Experience working with clinical packaging, labeling, and distribution vendors.
• Proficiency in supply forecasting and inventory management tools.
• Excellent project management and problem-solving skills.
• Strong interpersonal and communication skills to collaborate effectively with internal and external stakeholders.
• Ability to work in a fast-paced environment with shifting priorities.
• Experience with Interactive Response Technology (IRT) for clinical supply management.

Skills

• Project management
• Forecasting and inventory management
• Cross-functional collaboration
• Regulatory compliance (GMP/GDP/GCP/ICH/FDA/EMA)
• IRT proficiency
• Vendor management (packaging, labeling, distribution)

Education

• Bachelor's degree in a related field (e.g., Supply Chain Management, Life Sciences, Pharmacy, or Business)