logistics manager
3 the last 245 days, recently 2023-08-11
Responsibility
- company Description
- bicycle is headquartered in Cambridge, UK, and our US operations run out of Lexington, MA
- effective collation and management of IMP inventory in collaboration with both internal and external partners
Show more +22 - implements and monitors inventory management plans that may have complex supply chains
- implement and monitor inventory management plans that may have complex supply chains
- our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists focused on oncology indications with high unmet medical need
- where implemented, leverages the inventory management capabilities of the IRT to appropriately manage studies
- where implemented, leveraging the inventory management capabilities of the IRT to appropriately manage studies
- bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines
- strong communication skills and experience of managing multiple internal and external international partners is essential
- strong communication skills and experience of managing multiple internal and external international partners is essential in this role
- attend relevant study-related meetings and represent status of the Clinical Supply Chain as appropriate
- key Responsibilities
- ability to work as part of a cross-functional team for study management activities
- we have an exciting opportunity for an experienced CMC Logistics and Clinical Supply Chain Manager to join the Bicycle team and provide logistics support to our expanding preclinical and clinical portfolio
- establish and implement defined packaging, distribution and, if appropriate, IRT plan to supply study drug to global clinical trials using sound supply chain techniques
- reporting to the Associate Director, Clinical Supply Chain, the CMC Logistics and Clinical Supply Chain Manager will be responsible for ensuring that Investigational Medicinal Product is labelled, packaged, released, shipped, and distributed to clinical sites in a timely manner and in accordance with cGMP/GDP/GCP guidelines
- other duties may be assigned to meet the needs of the business
- reporting to the CMC Director, the CMC Logistics and Clinical Supply Chain Manager will be responsible for ensuring that Investigational Medicinal Product 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
- stays abreast and up to date with relevant cGMPs, GCPs, and other regulatory requirements/guidance and ensures study management activities are appropriately aligned
- stay abreast and up to date with relevant cGMPs, GCPs, and other regulatory requirements/guidance and ensures study management activities are appropriately aligned
- the CMC Logistics and Clinical Supply Chain 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 providers
- 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
Requirements
- essential requirements
- educated within relevant subject matters or equivalent career experience
- demonstrated Supply Chain experience, either in Logistics, IRT, and/or Packaging, with working knowledge of international shipment and import of IMP
Show more +10 - demonstrated experience in successfully managing projects in a proactive manner
- demonstrated experience with multiple global clinical trials
- proven track record of managing external service providers to ensure optimal delivery to time, cost and quality
- strong interpersonal skills and experienced in presenting to senior management
- good computing skills in MS Office suite software
- strong team player with good motivational skills, and ability to work independently and comfortable to lead
- ability to work in a flexible, collaborative style with colleagues and teams within the company and with external service providers
- ability to handle complex information
- additional Information
- state-of-the-art campus environment
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