The Associate Director, Clinical Supply Chain Management’s primary responsibility is to manage the clinical supply chain for Phase 1 to Phase IV compounds. The completion of clinical trials is the rate-limiting step for filing of new drug applications and, ultimately, to product commercialization. The on-time initiation, uninterrupted conduct, and completion of clinical studies is dependent on the timely delivery of clinical supplies of top quality to the clinical sites.

Responsibilities

• Define and implement a global clinical supply strategy, including the development of strategic options for the clinical supply chain.
• Ensure all clinical supplies (Phases I-IV, affiliate studies, and IIS) are delivered on time, on budget and of top quality with no studies interrupted or delayed due to clinical supplies
• Define and manage external budget for compounds (comparators, co-meds, over-encapsulation, depots, and importation costs)
• Represent the clinical supply chain on Integrated Evidence Strategy Teams (IESTs) and participate and contribute to Product Presentation and Device Strategy Team (PPDST) meetings
• Define API and drug product requirements and delivery dates to support the clinical supply chain
• Matrix management of a larger number of Clinical Supply Project Managers (CSPMs) supporting the global clinical supply chain
• Allocate bulk drug product to CSPMs, minimizing wastage
• Lead the recovery of clinical supplies during a product recall, support the evaluation and approval of non-medical complaints (NMCs), exception reports and recalls
• Demonstrate leadership skills by driving for continuous improvement and encouraging and supporting collaboration across departments. Represent CDSM Program Management on cross-functional and global initiatives which require clinical drug supply expertise.
• Bachelor’s Degree or higher in Pharmacy or Science.
• 8+ years’ experience in the pharmaceutical industry, preferably with CMC and/or clinical supplies management experience.
• Broad understanding of the overall drug development process.
• Experience in project management, planning, forecasting, budgeting.
• Excellent interpersonal, team, and leadership skills.
• Sound knowledge of GxP.

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AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.