Associate Director, Clinical Supply Chain Management

The Associate Director Clinical Supply Chain Managements 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.

Qualifications :

• Bachelors 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.

Additional Information :

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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time