- Job Type: Full-Time
- Function: IT
- Industry: Vaccine
- Post Date: 05/23/2023
- Website: www.vaxcyte.com
- Company Address: 353 Hatch Drive, Foster City, CA, 94404
About VaxcyteHigh-fidelity vaccines against pneumococcal infection and other bacterial infections
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 (PCV) 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 coverage of 31 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.
The Head of Enterprise IT Systems is accountable for the breadth of Vaxcyte’s IT-managed, enterprise system portfolio. For this position the term “enterprise” encompasses platforms, systems, tools and supporting technologies that benefit the broader Vaxcyte user population. This position actively partners and collaborates with business leaders to derive and drive value from existing and new technology investments, including forward-thinking integration, automation and analytical capabilities. Vaxcyte’s IT system landscape is, and will continue to be, nearly 100% multi-tenant cloud. As such, optimizing and coordinating internal and external talent across operational and project teams is essential. This is an exciting and engaging role that works with nearly every business function. This is a hands-on role that reports to the Vice President of IT and Facilities at Vaxcyte’s San Carlos, California headquarters.
- Work closely with IT leadership and business partners to evolve our IT strategic roadmap.
- Establish and nurture close, cross-functional business partnerships.
- Grow internal IT team commensurate with business and technology needs.
- Deliver strategic roadmap initiatives with a cloud-first, always-on and access-anywhere mentality.
- Partner with and manage 3rd party vendors for project delivery and operational managed services.
- Help establish, maintain, and deliver against IT’s Computer System Assurance (CSA) toolkit.
- Ensure system and operational compliance across regulatory needs (SOX, GxP, Privacy, etc.).
- Optimize system support structures to ensure a high level of end user satisfaction.
- Transition appropriate levels of our current enterprise system ownership into IT.
- Help develop data transfer agreements and technology solutions with 3rd party partners.
- Harden system security through best-practice authentication, monitoring, and employee training.
- Help build enterprise competency centers that span in-scope systems and technologies.
- Establish and/or help facilitate appropriate Change Review Boards.
- Own budget forecast, management and actuals tracking for in-scope technology spend.
- Closely manage and optimize license procurement and provisioning.
- Serve as IT Subject Matter Expert for regulatory audits as needed.
- Coach team on technical and procedural best-practices along with a customer-first attitude.
- Lead and/or coordinate Managed Services and internal techno-functional resources.
- Provide expert hands-on design and configuration assistance.
- Bachelor’s degree in IT or related discipline.
- 10+ years IT experience with a minimum of 5 years in the Life Sciences industry.
- 5+ years in managerial role that required hiring, leading, and developing IT employees.
- Working functional and systems experience across:
o G&A (Procurement, Punchout, Close Automation, Time Tracking, Contracts, HRIS)
o Quality (eDMS, eQMS, LMS)
o Regulatory (Submissions)
o Clinical (CTMS, eTMF)
o IT (SSO, SOA, Workflow Automation, Analytics, Cybersecurity)
- Hands-on experience with NetSuite and Veeva platforms required.
- Proven PM and operational experience delivering and maintaining enterprise IT systems.
- Hands-on knowledge in applying risk-based software validation methods (i.e., GAMP5).
- Working knowledge of regulatory requirements including SOX, GxP, HIPAA and GDPR.
- Exceptional interpersonal and consultative skills are an absolute must.
- Accountable and dependable; take personal responsibility for the quality and timeliness of work.
- Adaptable and flexible; adapt to changing business needs, conditions, and priorities.
- Thrive in a fast-paced, results-driven, and team-oriented environment.
- All Vaxcyte employees require vaccination against COVID-19.
Reports to: Vice President, IT & Facilities
Location: San Carlos, CA
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $253,000 - $270,000