Clinical Supplies Manager II
Exelixis
June 26, 2026
Remote friendly (Alameda, CA)
United States
$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 of IMP by coordinating with internal and external supply partners/vendors to ensure sufficient supply 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 CMOs for assigned studies to meet/exceed timelines.
- Ensure domestic and global distribution arrangements with external vendors for shipment following technical and regulatory releases.
- Create forecasts and packaging designs in collaboration with relevant partners to optimize supply plans.
- Partner with Quality Assurance and Regulatory Affairs to ensure supplies are labeled and released for global clinical site shipment.
- Cross-functionally develop IRT specifications and perform UAT.
- Design and/or review label text to meet product requirements and comply with US and international regulations.
- Represent clinical supplies at clinical trial team meetings; communicate plans and timelines to internal/external customers.
- Work with cross-functional teams on specifications and user testing of 3rd-party IRT systems.
- Ensure system documentation is transferred to TMF and inspection-ready.
- Utilize appropriate software/IT systems to manage key project activities.
Education/Experience
- BS/BA in related discipline + 7+ years; or MS/MA + 5+ years; or equivalent combination.
- Certification in assigned areas is a plus.
Required/Preferred Skills & Experience
- Demonstrated experience in clinical supply management (planning, labeling, packaging, distribution).
- Clinical supply management experience with contract manufacturing companies (strongly preferred).
- Working knowledge of IRT (e.g., IVRS, IWRS).
- GMP batch record development/review/approval knowledge.
- Knowledge of Interactive Voice/Web response systems.
- Working knowledge of clinical labeling/packaging/distribution regulations; GMP/GCP/GLP required.
- 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 of IMP by coordinating with internal and external supply partners/vendors to ensure sufficient supply 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 CMOs for assigned studies to meet/exceed timelines.
- Ensure domestic and global distribution arrangements with external vendors for shipment following technical and regulatory releases.
- Create forecasts and packaging designs in collaboration with relevant partners to optimize supply plans.
- Partner with Quality Assurance and Regulatory Affairs to ensure supplies are labeled and released for global clinical site shipment.
- Cross-functionally develop IRT specifications and perform UAT.
- Design and/or review label text to meet product requirements and comply with US and international regulations.
- Represent clinical supplies at clinical trial team meetings; communicate plans and timelines to internal/external customers.
- Work with cross-functional teams on specifications and user testing of 3rd-party IRT systems.
- Ensure system documentation is transferred to TMF and inspection-ready.
- Utilize appropriate software/IT systems to manage key project activities.
Education/Experience
- BS/BA in related discipline + 7+ years; or MS/MA + 5+ years; or equivalent combination.
- Certification in assigned areas is a plus.
Required/Preferred Skills & Experience
- Demonstrated experience in clinical supply management (planning, labeling, packaging, distribution).
- Clinical supply management experience with contract manufacturing companies (strongly preferred).
- Working knowledge of IRT (e.g., IVRS, IWRS).
- GMP batch record development/review/approval knowledge.
- Knowledge of Interactive Voice/Web response systems.
- Working knowledge of clinical labeling/packaging/distribution regulations; GMP/GCP/GLP required.
- Excellent project management and communication skills.
Working Conditions
- 20% travel to vendor sites, team meetings, and/or other offices.