Clinical Supplies Manager II
External job listingat Exelixis
Manage clinical supply activities for Exelixis, including packaging, labeling, inventory, distribution, IRT, and coordination with supply partners and vendors.
Salary
Not provided
Location
Alameda, United States
Employment type
Full time
Workplace
Not provided
Clinical Supplies Manager II
Alameda, United States
Job description
About the role
Exelixis is seeking a Clinical Supplies Manager II to oversee clinical supply management, including packaging, labeling, inventory monitoring, and distribution. The role involves working with internal and external supply partners and vendors to ensure investigational medicinal product supplies are sufficient at depots and clinical sites.
Responsibilities
- Lead clinical supply management activities and manage them through IRT from study start-up through study closure.
- Drive labeling, packaging, release, and distribution of clinical supplies at external CMO’s for assigned studies, meeting or exceeding project timelines.
- Ensure domestic and global distribution arrangements are in place so shipments can follow technical and regulatory releases.
- Work with relevant partners to create forecasts and packaging designs based on study needs and optimize the supply plan.
- Partner with Quality Assurance and Regulatory Affairs to ensure supplies are labelled and released for clinical site shipment for global clinical trials.
- Work cross-functionally to develop IRT specifications and perform user acceptance testing (UAT), including user testing for systems provided by third-party vendors.
- Design or review label text to meet product requirements and comply with US and international regulations.
- Represent clinical supplies at clinical trial team meetings and communicate plans and timelines to internal and external customers and partners.
- Ensure appropriate system documentation is transferred to TMF and ready for inspection.
- Use appropriate software and IT systems to manage key project activities.
Requirements
- BS/BA degree in a related discipline.
- A minimum of seven years of related experience.
Key facts
- The role oversees clinical supply management, including packaging, labeling, inventory monitoring, and distribution.
- Requirements include a BS/BA degree in a related discipline and a minimum of seven years of related experience.
- The role manages clinical supply activities through IRT from study start-up through study closure.
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Frequently asked questions
What does the Clinical Supplies Manager II role involve?
It oversees clinical supply management, including packaging, labeling, inventory monitoring, and distribution. It also manages clinical supply activities through IRT from study start-up through study closure.
What are the education and experience requirements?
The listing requires a BS/BA degree in a related discipline and a minimum of seven years of related experience.
What systems and partners does the role work with?
The role works with internal and external supply partners and vendors, and uses IRT, software, and IT systems to manage project activities.