Job Summary (Primary function)
The Associate Clinical Supply Director manages clinical supply chain of compounds in the clinical stage of development, and focuses on process change within Investigational Material Supply Chain (IMSC) in close collaboration with internal and external subject matter experts (SMEs).
Essential Functions of the Job (Key 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.
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 (Minimal acceptable level of education, work experience, and competency)
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.
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.
Strong analytical and problem-solving skills.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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