We have an exciting opportunity for an experienced CMC Senior Clinical Supplies Manager to join the Bicycle team and provide logistics support to our expanding preclinical and clinical portfolio.  Reporting to the Director, Clinical Supply Chain, the CMC Senior Clinical Supplies Manager will be responsible for ensuring that Investigational Medicinal Product (IMP) is labelled, packaged, released, shipped, and distributed to clinical sites in a timely manner and in accordance with cGMP/GDP/GCP guidelines. Inventory management and IMP use forecasting is a key function of the role, ensuring that IMP manufacturing campaigns are aligned with projected clinical usage to ensure uninterrupted supply.

You will have a track record of managing clinical supply chains for international clinical studies, as well as a strong practical understanding of the regulatory landscape for distribution of IMP.  Strong communication skills and experience of managing multiple internal and external international partners is essential.  

Key Responsibilities

The CMC Senior Clinical Supplies Manager works to ensure continuous supply of IMP for assigned clinical trials through effective monitoring and liaison with the internal CMC and clinical operations teams alongside proactive management of external distribution and Interactive Response Technology (IRT) providers.

You will have the responsibility for the day-to-day CMC inventory management and clinical supply chain management of all of the Bicycle Therapeutics clinical programs to include:

• Effective collation and management of IMP inventory in collaboration with both internal (CMC/Clinical) and external partners.
• Establish and implement defined packaging, distribution and, if appropriate, IRT plan to supply study drug to global clinical trials using sound supply chain techniques
• Implements and monitors inventory management plans that may have complex supply chains
• Sourcing of comparator drug
• Vendor management
• Where implemented, leverages the inventory management capabilities of the IRT to appropriately manage studies
• Stays abreast and up to date with relevant cGMPs, GCPs, and other regulatory requirements/guidance and ensures study management activities are appropriately aligned
• Attend relevant study-related meetings and represent status of the Clinical Supply Chain as appropriate
• Ability to work as part of a cross-functional team for study management activities
• Utilizes understanding of Clinical Trial Supply Chain Management best practice principles to suggest improvements to existing business processes and supports development of associated training material and documentation
• Other duties may be assigned to meet the needs of the business