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Job Details
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.
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.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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