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Clinical Supply Chain Associate Director
Our client is a Dublin-based clinical-stage biopharmaceutical developing new novel therapies. With a hugely experienced and successful executive management team this company is looking for an experienced Clinical Supply Chain AD.
Job Spec
The Clinical Supply AD is responsible for managing and ensuring a timely supply of clinical trial materials for clinical studies at all stages of development. Responsibilities include cross-functional planning for clinical demand and forecasting, management of supply chain vendors, inventory management at depots and sites, order management, import and export of GMP drug substance and drug products, returns, and destruction.
* Support labeling & packaging operations for clinical studies (Phase 1, 2 and 3)
* Coordinate and manage the distribution of Investigational products to depots and sites for clinical studies.
* Manage clinical packaging/distribution vendors including negotiating contracts, reviewing batch documentation, designing, and developing the distribution instructions.
* Participate in the setup, testing, and operation of interactive supply tracking systems.
* Serve as the interface between the CMC and clinical teams to ensure smooth conduct of clinical studies.
* Review departmental SOPs and ensure compliance with industry standards.
* Coordinate import and export of GMP materials.
* Maintain inventory database, systems, and documentation related to material receipt, storage, and distribution in compliance with regulatory requirements.
* Ensure compliance with Good Manufacturing Practices (GMP) and applicable state and federal regulatory requirements.
Person Spec
* BS or MS degree in chemistry, pharmacy, science, engineering or related fields
* Minimum 8 years industry experience in clinical operations or supply chain management for late-stage (Phase 3) multi-national clinical trials.
* Experience with managing contract organizations for clinical labeling, packaging, and distribution including cold chain
* Experience with clinical blinding practices and IWRS systems
* Familiarity with cGMPs.
* Working knowledge of import and export requirements in a regulated environment.
* Team player with demonstrated strong interpersonal skills, and clear oral and written communication skills
* Exceptional attention to detail, strong computer and organizational skills
* Proficiency with Microsoft Office Suite, strong Excel skill with experience building and maintaining drug forecast and distribution trackers and/or clinical inventory management system.
Seniority level
* Seniority level
Director
Employment type
* Employment type
Full-time
Job function
* Job function
Supply Chain
* Industries
Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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