Senior Manager, Investigational Supply Operations

JOB TITLE:                                                  Senior Manager, Investigational Supply Operations    

DEPARTMENT:                                          Technical Operations / CMC          

REPORTS TO:                                             Associate Director, Investigational Supply Operations

SUPERVISES:                                              N/A

FLSA STATUS:                                            Exempt

DATE PREPARED:                      

JOB SUMMARY:

The Senior Manager, Investigational Supply Operations, is responsible for coordination of investigational medicinal product (IMP) supply planning, labeling, packaging, distribution, inventory monitoring, and reconciliation for assigned clinical studies.

PRINCIPAL DUTIES:    

• Proactive planning for clinical supply including secondary packaging, labeling, storage, and distribution.
• Proposes packaging and labeling resupply schedules based on forecasts and production lead times.
• Develops strategies for proactively monitoring depot inventory levels and initiating resupplies or transfers to avoid supply interruptions to study sites.
• Manages external resources and vendors to accomplish defined clinical supply plans as necessary.
• Develop and maintain functional SOPs and controlled documents to ensure compliance to GMP/GCP.

·       Manage and tracks drug product shipments to clinical depots and sites.

·       Receive, triage, and resolve IMP temperature excursions.

·       Maintain inventory levels of packaging and distribution components.

·       Manage study closeouts and perform study-level reconciliation of IMP.

• Function as clinical supply point person on cross functional projects to identify and escalate supply risks.
• Provides input to IRT specification design. Reviews assigned IRT threshold levels to optimizes use of clinical supplies and prevent stock outs.
• Collaborate with Clinical Operations to develop and maintain Pharmacy Manuals for Clinical Trials.

REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS):

·       Ability to work well with changing priorities, strong attention to detail.

·       Ability to strategically plan, organize and manage multiple projects simultaneously.

·       Solid vendor management skills.

·       Exceptional project management abilities, particularly within complex clinical programs.

·       Ability to prioritize tasks/issues and identify risks in the future in a proactive manner. 

 ADDITIONAL PREFERRED QUALIFICATIONS/EXPERIENCE:

• Bachelor’s degree or higher, preferably in a science discipline, with at least 5 years in a position directly related to successfully managing clinical supplies. 

• Thorough understanding of GMP, GCP, and ICH standards governing IMP labeling, packaging, and global distribution.
• Demonstrated experience in managing multiple Phase 1-3 studies, including global clinical supply chains in the pharmaceutical and/or biotech industry.
• Understanding of the complete drug supply chain: Drug Substance/Drug Product/Regulatory Submissions and steps required for compliant drug release approvals and Global Importation logistics process.
• Proficiency in all aspects of Microsoft applications (Excel, Word, PowerPoint, Project, etc.), experience with automated applications (Excel, Word, PowerPoint, Project, etc.), experience with automated inventory systems, forecasting software and ERP Inventory management is a plus.
• Experience with electronic interactive response technologies (IRT) for inventory management.

This job description is intended to describe the general nature and level of the work being performed by employees in the position.  It is not intended to be a complete list of all responsibilities, duties, and skills for the position.  The Company reserves the right at all times, in its sole discretion, to add or subtract duties and responsibilities, as it deems necessary.