Lead the strategic and operational management of complex clinical supply activities across all phases of development
Collaborate with Clinical Operations/Development, Quality, Regulatory Affairs, and external partners to manage supply planning, inventory management, and distribution & logistics aligned with GMP and regulatory guidelines
Develop and implement end to end supply chain strategies from raw material to finished goods
Establish and manage vendor relationships for outsourced supply chain services
Manage labeling, packaging, distribution, and returns of IMP/CTM with external vendors in compliance with GMP and global regulations
Develop Interactive Response Technology (IRT) supply & return strategy
Actively monitor IMP inventory levels at global depots & clinical sites
Author study specific pharmacy manuals and supply related training materials

Bachelor’s or advanced degree with a minimum of 10 years of relevant pharmaceutical/biotech experience in supply chain management and operations
Experience in managing activities for global clinical trial supply, including but not limited to labeling, packaging, distribution, and IRT/IXRS inventory management in compliance with GMP and global regulations
Strong understanding of global regulatory requirements for IMP/CTM
External vendor selection and management experience
Experience with global supply chain, material movement, cold chain distribution, and logistics
Strong understanding of trade compliance and import/exports/customs requirements is a strong plus
Ability to manage multiple projects and to proactively identify risks and implement solutions
Excellent written & verbal communication with ability to work independently with minimal oversight
Strong interpersonal skills and ability to function in a dynamic team environment
Strong computer skills, with proficiency in spreadsheet, presentation, and word processing software
Flexibility to travel on company business as required

Associate Director, Clinical Supply Chain Management

Key skills