Director of Clinical Supplies

Director of Clinical Supplies

Located Near Brooklyn, NY

Compensation

Competitive

Responsibilities 

• Liaise closely with project management to determine required supply timelines
• Imply solutions/ideas for clinical packaging, especially around packaging design, function and blinding
• Work with the CMC development lead for a given project to obtain bulk product for clinical studies
• Coordinate with regulatory affairs to determine approved packaging, packing changes and clinical label design as required
• Prepare operating procedures for the clinical supplies discipline
• Work closely with Supply Chain to ensure investigative drug product reaches clinical site within publicized timelines 
• Participate in clinical packaging CROs to randomize, pack, label and ship product in a timely manner to the clinical sites
• Responsible for conceptualization, development, and implementation of clinical supply plans, based on the clinical study protocol and clinical development plans.    
• Plans, establishes, manages and monitors activities related to clinical supplies, to support the drug development process, in cooperation with internal and external customers and partners, and in compliance with regional / multinational regulations.
• Responsible for simple and complex studies requiring understanding of Good Manufacturing Practices, project management, IVRS, and supply management.
• Performs supply forecast models, contributes to the study specifications for IVRS studies, and provides medication management for complex studies using IVRS and other tools
• Ensures that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards

Requirements

• Bachelor’s degree in chemistry or pharmaceutics
• 10+ years’ experience in a clinical supply role
• Knowledge of scheduled (DEA II, III, IV) and non-scheduled drug import/export requirements (US, Canada, EU, etc.)
• Clinical development experience
• Computer database and Microsoft Office suite knowledge
• Clinical Trial Material (CTM) - understanding of the clinical packaging and labeling process.  
• Knowledge of the phases and processes within the clinical development environment
• Able to understand medical/therapeutic impact of products; understanding of potential product applications
• Must have worked at CRO’s in this discipline or have regularly outsourced to CRO’s