Associate Director, Clinical Supply Chain

This is a fully remote position, open to applicants in United States.

📋 Description

• Create and execute comprehensive clinical drug supply strategies for international clinical studies.

• Anticipate investigational product demand by analyzing enrollment, recruitment rates, protocol design, and country-specific needs.

• Formulate plans and address risks associated with drug demand and production.

• Collaborate with internal Elevar teams and external partners to oversee production, expiration, and inventory management.

• Partner with IRT vendors and systems to manage clinical trial supplies at manufacturers, distribution centers, and clinical sites.

• Contribute to the development of clinical pharmacy manuals, which include instructions for shipping, storage, and disposal.

• Coordinate with clinical sites for the disposal of unused or expired clinical supplies.

• Oversee drug shipment requests, monitor shipments, troubleshoot shipment issues, and address drug supply inquiries from clinical sites.

• Support import-export operations.

• Represent clinical supply on interdisciplinary study teams.

• Handle budget management and processes pertaining to global clinical supplies.

• Oversee the acquisition, labeling, packaging, shipping, and management of comparator drugs or co-administered medications.

⛳️ Requirements

• Bachelor’s degree in an engineering or scientific discipline.

• 12 years of experience in clinical supply, particularly in supporting late-stage clinical development programs.

• Familiarity with cGxP (GMP, GLP, GCP, etc.).

• Understanding of Interactive Response Technology (IRT).

• Knowledge of pertinent quality systems.

• Experience in managing packaging and labeling with Contract Manufacturing Organizations (CMOs).

• Strong written, verbal, and presentation communication skills.

• Proven ability to collaborate effectively in a remote working environment.

• Flexibility to work outside of standard business hours as required for the global clinical network.

🏝️ Benefits

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Paid time off.

• Retirement plan.

• Additional voluntary benefits.

• Competitive salary.