Job Description

Position Summary:

• As a member of the Supply Chain group, the Clinical Supply Chain Manager will act as the interface between the Supply Chain, Clinical Operations and Manufacturing groups to ensure timely availability of finished drug products and matching placebos for use in clinical studies.
• This role will oversee shipment and drug return logistical activities as well as over labeling by interacting with internal and external customers and suppliers in order to accomplish project objectives.
• Will represent Supply Chain in all relevant Clinical meetings and work with Clinical Operations to help develop IMP distribution and returns drug plans.
• The Clinical Supply Chain Manager also monitors inventory levels and provides feedback to the Clinical Operations team regarding expiry and re-supply.
• This position reports to the Director, Drug Product Manufacturing and Supply Chain.
  
• The clinical supplies manager will work directly with external and internal partners to ensure supply of IMP and Placebo to clinical sites located around the world.
  

Responsibilities:

• Work proactively to align with Clinical Operations/Study teams to help create forecast for each study and program including enrollment rate
  
• Act as the subject matter expert for clinical trial supply during regulatory inspections
  
• Help develop an Inventory strategy per program, study and region
  
• Monitor regularly drug expiry, and the appropriate inventory re-supply
  
• Provide monitoring of enrolment, drop-out rates and actual supply needs; ensures continuous re-assessment of project needs
  
• Responsible for the sourcing of comparators and matching placebo as needed
  
• Drive label creation and approvals process, including translations for all countries
  
• Support a vendor management process including RFP, and SOWs with vendors
  
• Develop and support the governance process with CMOs
  
• Work with vendors to generate inventory reports, and review regularly budget and spending for relevant studies
  
• Support regulatory filings including IND submission information, and audits from all health agencies
  
• Design, implement and oversee return and destruction of IMPs from sites
  
• Interface with members of Clinical Operations to provide and obtain information and to ensure on time delivery of products
  
• Manage temperature excursions during transportation
  

Requirements:

• BA/BS in a scientific field or equivalent with of 6 to 8 years experience in Supply Chain/Clinical Supply Chain
  
• Ability to effectively interact with all levels of internal and external management, including CROs
  
• Demonstrated excellence in project management and managing, tracking, and measuring project progress
  
• Clinical Supply management experience using contract manufacturing companies strongly preferred
  
• Work experience must include some of the following: drug development, project management, clinical trials management, manufacturing/packaging
  
• Working knowledge of regulations relating to clinical labeling, packaging and distribution activities (cGMP, GCP)
  
• A track record of successfully managing multiple projects within a cGMP related environment
  
• Ability to manage timelines and prioritize task execution based on business need
  
• Possesses excellent organizational, project management, technical, problem solving and communication (written & verbal) skills
  
• Ability to think both strategically and tactically with exceptional attention to detail
  
• Demonstrated ability to manage multiple high-priority projects concurrently in an often changing environment
  
• Able to work with a range of technically and culturally diverse people, influencing them to get the job done, and delivering value-added business results that meet high quality requirements within a tight schedule