Job DescriptionOur Oxford-based biotech client is growing and they are due to begin trials in clinic for cell-based therapeutics for treating life-threatening rare diseases later this year. This exciting opportunity offers the right individual the rare opportunity to take full ownership for the new clinical supply chain, including its creation and execution. This will involve interpreting a clinical trial protocol in conjunction with other study information to create an appropriate kit design and formulate a strong supply plan. The role also be responsible for managing internal and external partners, to ensure delivery of the supply plan in accordance with study timelines.
• Interpret clinical trial protocols to create and execute an effective clinical trial supply chain solution and create English master label text to co-ordinate and ensure on-time and compliant completion of clinical trial deliverables, including: IMP packaging labelling and distribution.
• Create and maintain demand forecasts and packaging plans so that packed clinical supplies are readily available in accordance. Initiate packaging campaigns with the assigned vendor and provide oversight to ensure on-time delivery.
• Interpret study data to ensure supply chain is maintained. Setup, monitor, and where necessary, update study assigned Interactive Response Technology (IRT) systems to ensure study inventory is effectively managed
• Create an appropriate distribution plan and have oversight of the assigned vendors and building a trusted and partnership relationship
• Remain up to date in all GxP and regulatory requirements applicable to the role facilitating internal stakeholder and external vendor related meetings where necessary to discuss clinical supply chain topics or status updates
• Creates a Temperature Excursion management plan responsible for the review and assessment process of Temperature Excursions and undertake regular risk management assessments to ensure all risks are systematically reviewed and appropriate mitigation is in place
Bachelor’s Degree (or equivalent)
Experience of managing an outsourced supply chain function
Experience working in Clinical Operations -or- Clinical Supplies.
Experience or working in a biotech environment would be an asset.
Knowledge of Regulations and general industry SOPs governing clinical supplies
Establishing strong external relationships within a professional clinical supply environment.
Strong organizational, prioritisation, project management and analytical skills
This role will involve working across several functions, representing and planning many coordinated efforts, working as an individual contributor, internally leading projects and ensure on-time delivery and also working with vendors and external process improvements.
Home working considered.