Associate Director, Drug Supply Management
ProClinical is working with a leading biotechnology company that is seeking an Associate Director, Drug Supply Management to be based in Boston on a permanent basis.
- Drive best practice for supply logistics and for the processes surrounding the supply
- Responsible for logistics as required to support the labelling, packaging and shipment of clinical drug supplies to depots/investigative sites as well as other clinical supplies necessary
- Oversee process for inventory control and distribution activities including scheduling, issue resolution, change implementation, vendor oversight and scope review related to clinical supplies
- Manages work with labelling and packaging vendors, Functional Leads
- Primary interface with CMC for Production Planning & Distribution; develops best practice for forecast of all drug supply needs
- Implements Industry Best Practices and templates for clinical drug supply activities.
- Responsible for coordinating and scheduling drug labelling and packaging activities in conjunction with CMC, clinical, regulatory departments as well as the workload of drug supply managers in the group
- Oversee vendor activities including procurement, labelling performance, on-time delivery, quality, improvement initiatives and issue resolution.
- Develop pharmacy manual in conjunction with relevant cross functional leads
- Develop drug and clinical supply training materials for investigational sites
Skills and Requirements:
- At least 8 years of clinical supply management experience in a clinical research environment and 5 additional years overall clinical operations experience
- Bachelor's degree in a science-based subject (advanced degree preferred)
- Prior Cold Chain distribution experience required.
- IRT implementation experience
- Prior Biopharmaceutical, pharmaceutical or chemical manufacturing experience preferred
- Creative, capable problem-solver
- Experience in establishing and maintaining relationships with vendors
- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements
- Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)
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.
In case you have difficulty in applying or if you have any questions, please call Alexander Tooulas on +44 207 437 6824 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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