Forecasting and Planning of Investigational Material
Directly oversee the development, implementation and maintenance of supply strategies that integrate the expertise of all CMC line functions to ensure effective use of investigational material based on study needs, the scientific confines of the drug's development and the regulatory requirements in the country of destination.
Directly oversees input provided to the study protocol for packaging designs and distribution plans.
Directs all activities associated with the management of investigational material inventories. Accountable for ensuring that the work performed by the forecasting and planning team is accurate, timely, efficient and compliant with corporate policies, SOPs, cGxPs and other applicable regulations.
Development and management of IM Forecasting and Planning organization
Facilitate continuous process improvement within IMSC resulting in cohesive supply chain activities.
Hire, train and retain team members to develop the second line of management
Instill a proactive culture and “can-do” attitude for all employees and to challenge them to volunteer new ideas resulting in increased operational efficiencies.
Motivate team member to be leaders.
May monitor and control labor and capitol expenditures
Minimum 12 years experience in pharmaceutical company or related industry
Must have at least 5 years experience in in drug development, clinical supply chain management and/or clinical manufacturing
Mist have 3-5 years experience supervising a functional unit
Strong background in cGxPs and ICH requirements.
Ability to force cross-functional partnerships and strategies.
Demonstrated skills in project management and handling multiple projects simultaneously
Thorough understanding of the drug development process
Demonstrated teamwork and collaboration skills