Clinical Supplies Manager - Remote

Overview

The Clinical Supplies Manager will provide leadership and support in the planning, development, and execution of clinical supply chain activities, ensuring timely planning and accurate forecasting for investigational supplies across all phases of clinical trials.

In Short

• Understand and translate clinical study protocol requirements into demand for drug product.
• Create initial supply forecasts and re-forecast as needed.
• Partner with cross-functional groups to meet study timelines.
• Manage drug supply function within IRT.
• Monitor inventory levels at depots and clinical sites.
• Manage label development and approval process.
• Oversee CMO for packaging, labeling, and distribution.
• Manage inspection readiness activities.

Requirements

• Bachelor's degree in a science, supply chain, or related discipline.
• 3+ years of relevant industry experience.
• Knowledge of ICH guidelines, GCP, CFR, and EMA GMP and GDP Guidelines.
• Understanding of roles and responsibilities in clinical supply.
• Excellent interpersonal and problem-solving skills.

Benefits

• Opportunity to work with a leading biotechnology company.
• Engagement in innovative clinical programs.
• Collaborative team environment.
• Flexibility in work arrangements.