🧪 About the Role
We are seeking a strategic and detail-oriented Clinical Supply Manager to oversee end-to-end clinical supply operations for global Phase I–IV studies. This role is critical to ensuring timely, compliant, and cost-effective delivery of investigational medicinal products (IMPs) across diverse geographies. You’ll collaborate cross-functionally with Clinical Operations, Regulatory Affairs, Quality Assurance, and external vendors to drive excellence in clinical supply planning and execution.
🔑 Key Responsibilities
* Clinical Supply Strategy & Planning
* Develop and implement global supply plans aligned with clinical study timelines and enrollment forecasts.
* Lead demand forecasting, inventory management, and supply risk mitigation strategies.
* Vendor & Logistics Management
* Manage relationships with CMOs, packaging vendors, and distribution partners.
* Oversee labeling, packaging, and global distribution of IMPs, ensuring compliance with local regulations.
* Cross-Functional Collaboration
* Partner with Clinical Project Managers, Regulatory, and QA to ensure seamless trial execution.
* Serve as the clinical supply point of contact for internal and external stakeholders.
* Compliance & Documentation
* Ensure adherence to GMP, GDP, ICH-GCP, and country-specific regulatory requirements.
* Maintain accurate documentation including supply plans, shipment records, and temperature excursions.
* Continuous Improvement
* Identify and implement process improvements to enhance supply chain efficiency and reliability.
* Support audits and inspections related to clinical supply activities.
🎓 Qualifications & Experience
* Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Supply Chain, or related field.
* Extensive experience in clinical supply management within the pharmaceutical or biotech industry.
* Proven experience supporting global clinical trials and managing external vendors.
* Strong knowledge of GMP/GDP, clinical trial logistics, and regulatory requirements.
* Excellent project management, communication, and problem-solving skills.
* Proficiency in supply chain systems and tools (e.g., ERP, IRT).
* Fluent in English; additional languages are a plus.