About this role
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 suppliesDefine 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) meetingsDefine API and drug product requirements and delivery dates to support the clinical supply chainMatrix management of a larger number of Clinical Supply Project Managers (CSPMs) supporting the global clinical supply chainAllocate bulk drug product to CSPMs, minimizing wastageLead the recovery of clinical supplies during a product recall, support the evaluation and approval of non-medical complaints (NMCs), exception reports and recallsDemonstrate 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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