Clinical Supplies Manager II
Exelixis
August 08, 2026
Remote friendly (Alameda, CA)
United States
$121,500 - $172,000 USD yearly
Operations
Summary/Job Purpose
The Clinical Supplies Manager II oversees all aspects of clinical supply management including packaging, labeling, inventory monitoring, and distribution of IMP by coordinating with internal and external supply partners/vendors to ensure sufficient supplies 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 to meet/exceed project timelines.
- Ensure domestic and global distribution arrangements with external vendors for shipment after technical and regulatory releases.
- Create forecasts and packaging design in collaboration with partners to optimize the supply plan.
- Partner with Quality Assurance and Regulatory Affairs to ensure supplies are labeled and released for global clinical trial shipments.
- Cross-functionally develop IRT specifications and perform UAT.
- Design and/or review label text to meet product requirements and US/international regulations.
- Represent clinical supplies in trial team meetings; communicate plans and timelines to internal/external stakeholders.
- Develop specifications and user testing for IRT systems from 3rd-party vendors.
- Ensure system documentation is transferred to TMF for inspection readiness.
- Use appropriate software/IT systems to manage project activities.
Education/Experience
- BS/BA related discipline + 7+ years; or MS/MA related discipline + 5+ years; or equivalent combination.
- Certification in assigned areas is a plus.
Experience/Skills (Preferred/Required)
- Clinical supply management experience (planning, labeling, packaging, distribution).
- Contract manufacturing company experience strongly preferred.
- Working knowledge of IRT (IVRS/IWRS).
- Knowledge of GMP batch record development/review/approval.
- Knowledge of clinical labeling/packaging/distribution regulations; GMP/GCP/GLP required.
- Knowledge of Interactive Voice/Web response systems.
- Excellent project management and communication skills.
Working Conditions
- 20% travel.
Application Instructions
- If you have a disability and need an accommodation in relation to the recruiting process, email ApplicantAccommodations@exelixis.com.
The Clinical Supplies Manager II oversees all aspects of clinical supply management including packaging, labeling, inventory monitoring, and distribution of IMP by coordinating with internal and external supply partners/vendors to ensure sufficient supplies 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 to meet/exceed project timelines.
- Ensure domestic and global distribution arrangements with external vendors for shipment after technical and regulatory releases.
- Create forecasts and packaging design in collaboration with partners to optimize the supply plan.
- Partner with Quality Assurance and Regulatory Affairs to ensure supplies are labeled and released for global clinical trial shipments.
- Cross-functionally develop IRT specifications and perform UAT.
- Design and/or review label text to meet product requirements and US/international regulations.
- Represent clinical supplies in trial team meetings; communicate plans and timelines to internal/external stakeholders.
- Develop specifications and user testing for IRT systems from 3rd-party vendors.
- Ensure system documentation is transferred to TMF for inspection readiness.
- Use appropriate software/IT systems to manage project activities.
Education/Experience
- BS/BA related discipline + 7+ years; or MS/MA related discipline + 5+ years; or equivalent combination.
- Certification in assigned areas is a plus.
Experience/Skills (Preferred/Required)
- Clinical supply management experience (planning, labeling, packaging, distribution).
- Contract manufacturing company experience strongly preferred.
- Working knowledge of IRT (IVRS/IWRS).
- Knowledge of GMP batch record development/review/approval.
- Knowledge of clinical labeling/packaging/distribution regulations; GMP/GCP/GLP required.
- Knowledge of Interactive Voice/Web response systems.
- Excellent project management and communication skills.
Working Conditions
- 20% travel.
Application Instructions
- If you have a disability and need an accommodation in relation to the recruiting process, email ApplicantAccommodations@exelixis.com.