Clinical Supplies Manager II
Exelixis
August 30, 2026
On-site
Alameda, CA
$121,500 - $172,000 USD yearly
Operations
Summary/Job Purpose
The Clinical Supplies Manager II oversees clinical supply management, including packaging, labeling, inventory monitoring, and distribution, to ensure IMP supply is sufficient at depots and clinical sites.
Essential Duties and Responsibilities
- Lead clinical supply management functionality.
- Monitor and manage clinical supply activities 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 to meet/exceed timelines.
- Ensure domestic and global distribution arrangements with external vendors for shipments following technical and regulatory releases.
- Create forecasts and packaging design with partners to optimize supply plans.
- Partner with Quality Assurance and Regulatory Affairs to ensure supplies are labeled and released for global clinical site shipment.
- Work cross-functionally to develop IRT specifications and perform UAT.
- Design and/or review label text to meet product requirements and US/international regulations.
- Represent clinical supplies in clinical trial team meetings; communicate plans and timelines to internal/external stakeholders.
- Develop IRT specifications and conduct user testing with teams for 3rd-party IRT systems.
- Ensure system documentation is transferred to TMF and ready for inspection.
- Use appropriate software/IT systems to manage key project activities.
Education/Experience
- BS/BA in related discipline + 7 years’ experience; or MS/MA + 5 years; or equivalent combination.
- Certification in assigned areas is a plus.
Required/Preferred Experience & Skills
- Demonstrated clinical supply management experience (planning, labeling, packaging, distribution).
- Clinical supply management using contract manufacturing companies (strongly preferred).
- Working knowledge of IRT (IVRS/IWRS).
- Knowledge of GMP batch record development, review, approval; GMP/GCP/GLP regulations.
- Knowledge of regulations for clinical labeling, packaging, and distribution.
- Knowledge of Interactive Voice/Web response systems.
- Excellent project management and communication skills.
Working Conditions
- 20% travel to vendor sites, team meetings, and/or other offices.
The Clinical Supplies Manager II oversees clinical supply management, including packaging, labeling, inventory monitoring, and distribution, to ensure IMP supply is sufficient at depots and clinical sites.
Essential Duties and Responsibilities
- Lead clinical supply management functionality.
- Monitor and manage clinical supply activities 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 to meet/exceed timelines.
- Ensure domestic and global distribution arrangements with external vendors for shipments following technical and regulatory releases.
- Create forecasts and packaging design with partners to optimize supply plans.
- Partner with Quality Assurance and Regulatory Affairs to ensure supplies are labeled and released for global clinical site shipment.
- Work cross-functionally to develop IRT specifications and perform UAT.
- Design and/or review label text to meet product requirements and US/international regulations.
- Represent clinical supplies in clinical trial team meetings; communicate plans and timelines to internal/external stakeholders.
- Develop IRT specifications and conduct user testing with teams for 3rd-party IRT systems.
- Ensure system documentation is transferred to TMF and ready for inspection.
- Use appropriate software/IT systems to manage key project activities.
Education/Experience
- BS/BA in related discipline + 7 years’ experience; or MS/MA + 5 years; or equivalent combination.
- Certification in assigned areas is a plus.
Required/Preferred Experience & Skills
- Demonstrated clinical supply management experience (planning, labeling, packaging, distribution).
- Clinical supply management using contract manufacturing companies (strongly preferred).
- Working knowledge of IRT (IVRS/IWRS).
- Knowledge of GMP batch record development, review, approval; GMP/GCP/GLP regulations.
- Knowledge of regulations for clinical labeling, packaging, and distribution.
- Knowledge of Interactive Voice/Web response systems.
- Excellent project management and communication skills.
Working Conditions
- 20% travel to vendor sites, team meetings, and/or other offices.