Job DescriptionMy client is a pioneering immunology company leading the market in allergy vaccines. They have developed an innovative approach to medical treatments over several decades and are in an exciting phase of expansion across Europe and the USA. The company has an excellent reputation for its welcoming atmosphere, staff morale and ongoing career development.
To design, plan and execute all matters related to the supply of investigational product, companion diagnostics and ancillary supplies to meet the requirements of the patients, investigators and business objectives
Clinical Supply (80%)
• Act as the primary point of contact for all matters related to the supply of clinical trial material
• Translate the clinical trial protocol or study plan into a comprehensive clinical supply strategy
• Forecasting the amount of clinical trial material required
• Developing a pharmacy manual to support investigational teams at study sites to prepare accurate doses
• Collaborating in building the RTSM
• Lead clinical trial supply vendor selection process from request for information to award
• Liaise with the Early Phase Project Manager to ensure supply chain logistics are consistent with requirements for transfer of materials, e.g. requirements for cold chain, product shelf-life and interpretation of study protocols.
• Execute all project specific activities related to IMP, NIMP and Ancillary
Systems and change management (20%)
• Provide user-friendly stock inventory management forecasting tool based upon R&D roadmap. Ensure logistical issues in planning forecast and acceptance of stock from manufacturing operations.
• Ensure all change triggered by stock request is considered as justification for change control
• Relevant experience of clinical supply chain management
• Pharmacist background is preferred
• Experience of vendor/ contractor management and collaboration.
• Knowledge of complexity in clinical supply chain logistics
• Understanding ICH, EMEA, MHRA and FDA guidance documents, regulatory documents and QMS in a clinical setting.
The successful candidate will ideally have a background as a Pharmacist or Pharmacy Technician, with experience that has included clinical supply chain management and supply chain logistics. You will need to have worked in a clinical trial-related setting, whether in a CTS organisation, a Pharma company or another environment related to clinical supply, forecasting and stock inventory management. You will need to demonstrate an understanding of ICH, EMEA, MHRA and FDA guidelines, and quality management systems in a clinical setting. We are looking for an astute, versatile individual who has formed and developed collaborative partnerships with 3rd party vendors and has experience of vendor selection and management. You must be able to demonstrate the ability to learn, listen actively to others, and build mutually beneficial relationships.
Flexible working offered.