Job description
Company Profile:
Vaxcyte, Inc. (Nasdaq: PCVX) is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Vaxcyte’s lead candidate, VAX-24, is a 24-valent, broad-spectrum pneumococcal conjugate vaccine being developed for the prevention of invasive pneumococcal disease (IPD). The Company is re-engineering the way highly complex immunizations are made through modern synthetic techniques, including advanced chemistry and our exclusively licensed XpressCFTM cell-free protein synthesis platform. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of greater than 30 strains; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease. The Company is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit www.vaxcyte.com.
Vaxcyte, headquartered in San Carlos, CA, went public in June 2020 and currently has a team of approximately 150 employees and anticipates continued, significant growth. Following the October 2022 follow-on equity offering, which generated approximately $651 million in net proceeds, the Company’s balance sheet is further strengthened to advance its pipeline of novel vaccines, including VAX-24. On October 24, 2022, the Company announced positive topline safety, tolerability and immunogenicity data from the Phase 1/2 proof-of-concept study evaluating VAX-24 in adults aged 18-64. The Company believes these results support a best-in-class potential for VAX-24, which was designed to replace the current standard-of-care in adults and children. VAX-24 is being investigated for the prevention of IPD, which can be most serious for infants, young children, older adults and those with immune deficiencies or certain chronic health conditions. Given the global impact of pneumococcal disease remains significant, the public health community continues to advocate for vaccines that can offer broader protection to prevent IPD. Vaxcyte’s PCV franchise, consisting of VAX-24 and VAX-XP, is designed specifically to address this need and has the potential to deliver the broadest protection for this very serious disease. We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.
Summary:
This role leads the Clinical Supply team and has full accountability to ensure that all clinical trials have the right material at the right time so that trials can start as planned and proceed without any interruption or risk of interruption. Responsibilities include management of clinical secondary packaging sites / central depots and related vendors, demand /supply planning and execution of clinical packaging and labelling.
Essential Functions:
- End-to-End clinical trial supply management from study startup to end of trial reconciliation and destruction for Vaxcyte vaccine and comparator.
- Ensure clinical sites always have adequate inventory on hand so that trials can start on time and subject treatments are not interrupted due to lack of vaccine or comparator.
- Clinical secondary packaging site / central depot selection, contract negotiations, and site management
- Key interface between Manufacturing / Supply Chain, Process Development, Clinical Operations, Clinical Regulatory, Quality, Program Management and Clinical Secondary Packaging site / Central Depot
- Clinical supply SME on all distribution calls, IRT, and study team meetings.
- Lead weekly / biweekly cross functional meetings to ensure planning and execution of packaging runs is on track
- Ensure blinding strategy is maintained.
- Develop/revise forms, SOPs and work instructions (IP Supply Management, IP Label Generation, Temperature Excursions, IP Destruction, Chain of Custody Form, etc.).
- Selection, training, and continuous development of clinical supply team members.
- Create and manage department budgets and approve invoices.
- Identify and implement opportunities to optimize and/or de-risk Clinical supply.
- Manage demand / supply planning and supply execution:
- Determine vaccine & comparator demand based on protocol, # of sites, shelf life, & risk.
- Translate demand plan into a supply plan (#, timing volume of packaging runs).
- Scenario planning based on potential different protocol designs or supply chain risks.
- Develop detailed project plan for each packaging run.
- Monitor execution of packaging plan and resolve / escalate issues as needed.
- IP label/proof development following regulatory guidelines.
- Batch records review/approval.
- Collaborate with QA on central depot document management in Veeva.
- Partner with Clinical on IRT selection, implementation, and UAT.
- Inventory management for depots and clinical sites.
- Monitor trial execution vs plan and drug shelf life and adjust supply plan as needed to maintain supply continuity.
- Maintain Clinical supply dashboard and metrics.
- Maintain Batch Genealogy database.
- Resolve temperature excursions in storage depots, shipping and at clinical sites.
- Perform inventory reconciliation at end of trial.
- Ensure excess inventory at end of trial is disposed of in a compliant manner.
Requirements:
- B.S. / B.A. degree or Advanced Degree (preferred).
- 7-12 years’ experience working in Clinical Supply Management.
- Experience with regulatory labeling requirements for clinical trials (US/ex-US).
- Strong Knowledge of GMPs.
- Experience managing Cold Chain shipping.
- Strong Experience leading Cross-Functional teams.
- Excellent communication skills.
- Strong CMO relationship management skills.
- All Vaxcyte employees require vaccination against COVID-19.
Reports to: Executive Director, Global Supply Chain
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $207,000 - $225,000
Send resumes to:
careers@vaxcyte.com
Vaxcyte, Inc.
825 Industrial Road, Suite 300
San Carlos, CA 94070
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