Sr Clinical Supply Project Manager/Clinical Supply Project Manager

Clinical Supply Management (CSM) is a part of the Clinical Drug Supply Management (CDSM) organization within R&D Development Sciences. CSM is responsible for the management, planning, packaging, labeling, and distribution of investigational products and clinical trial materials to support all AbbVie Phase I to Phase IV studies, along with Investigator Initiated Studies and Compassionate Use situations.

Major Job Responsibilities

• Responsible for the project management of key Clinical Supply Chain activities at the protocol level for Phase 1, 2, 3, 4 and IIS studies of increasing complexity
• Includes forecasting, planning, scheduling, coordination and execution, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots.  
• Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient utilization of supply chain resources.
• Translates clinical study design into packaging design. Authors the study medication and labeling section of the clinical protocol.
• Develops protocol specific labeling compliant with applicable global regulations.
• Identifies, develops, communicates and tracks project timelines, activities, logistics, and milestones.
• Responsible for creating appropriate protocol specific manufacturing and packaging work orders in concert with Third Party and IVRS vendors, QA, clinical team partners etc to ensure timely availability of clinical supplies.
• Responsible for protocol specific clinical supplies scenario analysis, risk management and contingency planning. Forecasts protocol specific bulk drug product requirements, including comparator agents, ancillary supplies and commodities, including overages

Education/ Experience

• Bachelor’s Degree required, preferably in physical science, math, engineering, or pharmacy
• 5- 8 years total experience in the Pharmaceutical Industry 

*Grade level commensurate with education and experience.

*Work location can be flexible (remote or other AbbVie sites outside of the Bay Area can be considered)