Clinical Supply Manager
A clinical stage biopharmaceutical company is looking for an experienced Clinical Supply Manager to join their growing company. This position is home based. The organisation is currently developing a new class of ImmunoTherapeutics, targeting infectious diseases and cancers based on its proprietary arenavirus platform that is designed to reprogram the body's immune system. Due to the recent growth of the company, my client is looking for a experienced clinical drug supply manager to set up the department from scratch. This will include setting a foundation for IV drug formulation, drug forecasting and hiring more people to grow the supply chain team. This position is great for someone who enjoys growing something from scratch and being the go to person when it comes to drug supply.
- Provides strategic direction for clinical supply chain planning activities for clinical trial studies
- Actively participates in project team meetings to work with cross functional teams including Technical Development, Clinical Operations, Regulatory Affairs, and Quality Management to provide feedback from a clinical supply chain perspective.
- Provide oversight to CMOs for labelling and packaging, drug depot service, transportation logistics, IMP relabelling coordination.
- Develops the program level demand planning forecasts and budgets based on the book of work for clinical drug supplies through all phases of clinical development for assigned programs Monitors ongoing study level activity to ensure sufficient supply. Manage inventory targets and safety stock levels.
- Develop a labelling strategy that meets regulatory and study requirements. Lead the development and approval of label text and label proofs including country-specific translations.
Skills and Requirements
- 5+ years' experience in production planning and inventory control in the bio/pharmaceutical industry.
- Experience with working with biological safety product(s) 1 and/or 2 is preferred.
- Experience working with IV formulation
- Drug forecasting
- General knowledge of current GMP/GCP/GDP regulations.
- Collaborative team player with strong interpersonal skills and ability to drive team actions and results.
- English as a native language or other nationality with top quartile English capabilities (reading and writing)
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
A full job description is available on request.