Associate Director, Global Clinical Supply Chain

Role Summary

The Associate Director, Global Clinical Supply Chain leads the clinical supply chain for compounds in the clinical stage of development, focusing on process improvements within the Investigational Material Supply Chain (IMSC) in collaboration with internal and external subject matter experts. The role serves as a key interface with contract manufacturers and cross-functional teams to ensure timely, compliant delivery of clinical materials.

Responsibilities

• As a key interface and SME for IMSC Operations, drive process change and improvement initiatives with contracted CMOs, Technical Operations, Medical Affairs, Quality and Clinical Operations, etc., as needed, to ensure effectiveness and efficiency.
• Support training, development and mentoring indirect reports, as needed.
• Develop strong internal collaboration with stakeholders, such as Clinical Operations, Project Management, Regulatory, Medical Affairs, Quality and Technical Operation functions to ensure successful delivery of clinical supply.
• Act as a key interface between the Contract Manufacturing Organization (CMO) and clinical teams, serving as a point of escalation, for clinical supply issues, ensuring clear communication and collaboration across diverse teams.
• Manage all aspects of clinical study requirements and Clinical Packaging activities.
• In collaboration with Clinical / Technical Operations and Project management, establish and meet timelines for clinical supplies available for clinical trials, managing inventory of clinical supplies before and during clinical studies.
• Identify external packaging sites, monitors external clinical packaging, and reviews master batch records.
• Coordinate GMP auditing activities at CMOs.
• Provide management with accurate time frames for resolution of delays in obtaining supplies for clinical projects.
• Recommend insight and recommendations into procedural improvements, as needed, and assist in the implementation of the improvements.
• Develop and manage strategic alliances with contract partners for procurement, packaging, transportation, brokerage, storage and distribution.

Qualifications

• Degree (such as Bachelor's or Master's) in a relevant field with significant experience in managing clinical packaging, clinical inventory and distribution, or equivalent experience.
• Knowledge of US and Global clinical labeling, Ex-US depot and Qualified Person requirements for clinical supplies required.
• Ability to work both independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Working knowledge of drug development process (Phase I-IV).
• Working knowledge of cGMPs and familiarity with US and EU regulations.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.