Clinical Supplies Manager II
Exelixis
6 hours ago
Remote friendly (Alameda, CA)
United States
$121,500 - $172,000 USD yearly
Operations
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; ensure project timelines are met or exceeded.
- Ensure domestic and global distribution arrangements are in place with external vendors to allow shipment following technical and regulatory releases.
- Create forecasts and packaging design in collaboration with partners to support an optimized supply plan.
- Partner with Quality Assurance and Regulatory Affairs to ensure supplies are labeled and released for clinical site shipment for global trials.
- Work cross-functionally to develop IRT specifications and perform UAT.
- Design and/or review label text to meet product requirements and comply with US and international regulations.
- Represent the clinical supplies function at clinical trial team meetings; communicate plans and timelines to internal/external stakeholders.
- Support development of IRT system specifications and user testing with cross-functional teams and 3rd-party vendors.
- Ensure system documentation is transferred to TMF and ready for inspection.
- Use appropriate software/IT systems to manage key project activities.
Qualifications:
- BS/BA degree in a related discipline with at least 7 years of related experience; or MS/MA with at least 5 years; or equivalent education and experience.
- Certification in assigned areas is a plus.
- Demonstrated experience in clinical supply management planning, labeling, packaging, and distribution.
- Clinical supply management experience using contract manufacturing companies (strongly preferred).
- Working knowledge/experience with Interactive Response Technologies (IRT) such as IVRS and IWRS.
Skills/Knowledge:
- Willingness to work in a fast-paced, evolving environment.
- Knowledge of GMP batch record development, review, and approval processes.
- Knowledge of Interactive Voice/Web response systems for clinical studies.
- Working knowledge of regulations for clinical labeling, packaging, and distribution; GMP/GCP/GLP required.
- Excellent project management and communication skills.
Working Conditions:
- 20% travel to vendor sites, team meetings, and/or other offices.
Benefits:
- Base pay range: $121,500 - $172,000 annually.
- 401k with generous company contributions; group medical, dental, and vision; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales).
- Opportunity to purchase company stock; long-term incentives.
- 15 vacation days (first year), 17 paid holidays (including winter shutdown in December), up to 10 sick days throughout the calendar year.
- 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; ensure project timelines are met or exceeded.
- Ensure domestic and global distribution arrangements are in place with external vendors to allow shipment following technical and regulatory releases.
- Create forecasts and packaging design in collaboration with partners to support an optimized supply plan.
- Partner with Quality Assurance and Regulatory Affairs to ensure supplies are labeled and released for clinical site shipment for global trials.
- Work cross-functionally to develop IRT specifications and perform UAT.
- Design and/or review label text to meet product requirements and comply with US and international regulations.
- Represent the clinical supplies function at clinical trial team meetings; communicate plans and timelines to internal/external stakeholders.
- Support development of IRT system specifications and user testing with cross-functional teams and 3rd-party vendors.
- Ensure system documentation is transferred to TMF and ready for inspection.
- Use appropriate software/IT systems to manage key project activities.
Qualifications:
- BS/BA degree in a related discipline with at least 7 years of related experience; or MS/MA with at least 5 years; or equivalent education and experience.
- Certification in assigned areas is a plus.
- Demonstrated experience in clinical supply management planning, labeling, packaging, and distribution.
- Clinical supply management experience using contract manufacturing companies (strongly preferred).
- Working knowledge/experience with Interactive Response Technologies (IRT) such as IVRS and IWRS.
Skills/Knowledge:
- Willingness to work in a fast-paced, evolving environment.
- Knowledge of GMP batch record development, review, and approval processes.
- Knowledge of Interactive Voice/Web response systems for clinical studies.
- Working knowledge of regulations for clinical labeling, packaging, and distribution; GMP/GCP/GLP required.
- Excellent project management and communication skills.
Working Conditions:
- 20% travel to vendor sites, team meetings, and/or other offices.
Benefits:
- Base pay range: $121,500 - $172,000 annually.
- 401k with generous company contributions; group medical, dental, and vision; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales).
- Opportunity to purchase company stock; long-term incentives.
- 15 vacation days (first year), 17 paid holidays (including winter shutdown in December), up to 10 sick days throughout the calendar year.