Responsibilities:
- Lead and conduct clinical programs associated with Investigational Medicinal Product Management (IMPM) activities, such as but not limited to demand planning, definition of supply strategy, set up of clinical supply chain, set up of IRT systems
- Monitoring and analysing project performance to anticipate obstacles and resolve issues in cooperation with supporting functions to ensure project milestones are met, continuous improvement by identifying opportunities
- Lead the development and establishment of an agreed storage, labelling and packaging specification, supply & distribution strategy under full GxP compliance
- Establishing, optimization, standardization and harmonization of IMPM processes and documentation across multiple clinical trials with very high complexity
- Representing IMPM team in internal and external project and study teams, organize and facilitate meetings.
Experience Required:
- Minimum of 5 years of experience in the pharmaceutical industry or biotechnology
- Proven track record of clinical supply chain, logistics set up & management
- Implementation & maintenance of IRT systems in global clinical trials up to Phase III
- Proven track record of Clinical PM experience in pharmaceutical or biotech industry
- Sound knowledge in relevant legislation and international GxP guidelines.