Description

This role plays a critical part in ensuring the smooth and efficient supply of investigational drugs for clinical trials. This position will be responsible for all aspects of clinical supply and logistics for multiple global trials including forecasting, inventory management, labeling, packaging, distributions, and drug accountability, etc. This position will be accountable for overseeing various activities related to clinical trial material supply to ensure that investigational medicinal products reach clinical trial sites promptly and safely. He/She will work closely with cross function teams (Clinical Ops, CMC, QA, Regulatory) to establish forecasting, resupply planning and timeline. The person will represent the clinical supply chain and contribute to cross-functional project teams, support Regulatory Filing and Inspection.

Essential Job Responsibilities:

• Responsible for managing the clinical supply chain for multiple global oncology clinical trials. 
• Formulate and implement strategies for global CTM supply.
• Collaborating with internal and external cross-function teams to establish forecasting, resupply planning and timeline, allocate bulk drug products, and minimize wastage.
• Oversee various clinical trial material (CTM) supply activities at depots and clinical sites.
• Manage importation/exportation, Custom Clearance, QP services to ensure investigational medicinal product (IMP) reach clinical trial sites promptly and safely. 
• Responsible for vendor selection and management, IMP procurement, contract and agreement, budget planning, invoice review/approval.
• Ensure all processes adhere to relevant GMP, GCP, GDP and ICH guidelines.
• Monitor and document KPIs related to vendor performance, on-time global investigational drug distribution, temperature excursion, quality issues. 
• Lead pharmacy manual development, temperature excursion management procedures.
• Develop SOPs related to supply chain management, label design/approval/production.
• Review IMP database (depot, ITR, EDC tracking system) to ensure accurate drug reconciliation.
• Prepare IMP consumption reports and present at team meetings. 
• Contribute and implement departmental policies and procedures. 
• Establish/support a work environment of continuous improvement. 

Requirements

Below requirements are minimum for a manager position in Regulatory.

• Bachelor’s degree, graduate education a plus.
• At least 5 years of experience managing supply chain for global oncology clinical trials. 
• Ability to handle complex projects in oncology product development at various stages to ensure cost and timeline while ensuring regulatory compliance. 
• Excellent organizational skills with attention to detail.
• Strong interpersonal skills and the ability to work in a fast-paced team environment.