Associate Director, Clinical Supplies

PTC Therapeutics seeks an Associate Director of Clinical Supplies to oversee forecasting, planning, packaging, labeling, distribution, and reconciliation of clinical trial materials across global studies. The role manages contract manufacturing organizations and distribution partners while ensuring regulatory compliance with cGMP, GCP, and ICH guidelines.

Responsibilities

• Oversee forecasting, planning, packaging, labeling, and distribution of clinical trial materials globally
• Manage relationships with contract manufacturing organizations, CROs, and distribution partners
• Lead label design, translations, and regulatory compliance for investigational products
• Manage clinical supplies budgets, vendor negotiations, and purchase orders
• Monitor inventory levels, manage expired supplies, and track temperature excursions at distribution sites

Requirements

• Experience reading, interpreting, and providing feedback on clinical protocols
• Proficiency managing clinical supply forecasting and demand planning
• Knowledge of packaging, labeling design, and regulatory requirements for clinical trials
• Experience managing vendor relationships, contract negotiations, and budgets
• Expertise in inventory management and IMP tracking systems
• Understanding of cGMP regulations, GCP, FDA, and ICH guidelines