- Job Type: Full-Time
- Function: Clinical Research
- 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, carrier-sparing 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-31, a 31-valent PCV candidate; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine program designed to prevent Shigella. 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 180 employees and anticipates continued, significant growth. Following equity offerings in October 2022 and April 2023, which generated over $1.1 billion in net proceeds, the Company’s balance sheet is further strengthened to advance its pipeline of novel vaccines, including VAX-24. These financings followed positive data readouts from Vaxcyte’s Phase 1/2 proof-of-concept study evaluating VAX-24 in adults aged 18-64 and Phase 2 study in adults 65 and older. 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-31, 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.
Vaxcyte is seeking an Associate Director of Clinical Operations to develop and implement clinical trial conduct of multiple clinical studies. They will manage or oversee clinical trials in accordance with the protocols, company SOPs, GCP, and other applicable regulatory requirements, and lead and direct Clinical Operations team members in the management of contract research organizations (CROs) and other trial vendors. Vaccine clinical operations experience is required. The Associate Director contributes Clinical Operations expertise in cross-functional and clinical operation meetings. Management and mentoring of Clinical Operations staff are expected.
To be successful, the incumbent will be a strong collaborator and communicator, possessing outstanding clinical operations skills and an attitude that fits our culture in a high growth, fast-paced environment. The position will be remotely based with some travel to the San Carlos, CA office.
- Assist in creating and executing Clinical Operations' systems, processes, and Standard Operating Procedures (SOPs), and regulatory inspection-readiness activities, in accordance with ICH/GCP guidelines and company policies.
- Implement and oversee all aspects of clinical operations from planning to executing clinical trials (RFP, site selection, start-up, enrollment, maintenance, and close-out).
- Responsible for project management and oversight of individual studies as well as relevant program-related activities with minimal supervision including managing team meetings (Agendas, Minutes, Action Items, Follow Up).
- Establish study/program milestones and ensure accurate tracking and reporting of study/program metrics, timelines, and critical study activities.
- Develop and maintain enrollment and budget forecasts.
- Participate in the selection of CRO and vendors including the development of RFPs, budget negotiations, and review of contracts.
- Oversee performance of CROs and third-party vendors to ensure compliance with study protocol and in accordance with scope of work and identify areas of concern and escalation.
- Perform and document study level Sponsor Oversight of outsourced clinical activities.
- Identify and drive process improvement initiatives in collaboration with cross functional leaders.
- Create and/or provide oversight and review on ICFs, protocols/amendments, IB, pharmacy manual, laboratory manual, and site budget/CTA.
- Provide oversight and review on study plans, including vendor oversight, risk, safety, and communication.
- Oversee Clinical Operations (CRAs, CTMs) that are responsible for managing CROs and third-party vendors to ensure delivery against the contracted scope of work and budget.
- Provide supervision and mentoring to clinical staff.
- Partner across Clinical Operations to embed quality and GCP compliance within day-to-day activities.
- Champion an inclusive mindset and approach, and foster collaboration and consistency across studies and programs.
- Proactively identify risks and develop and implement mitigation strategies.
- Must have experience in vaccine clinical operations.
- Level commensurate with experience.
- BS/BA in Life Sciences or related discipline.
- Ideal candidate will have at least 10 years of relevant clinical trial experience and a minimum of 1 year supervisor experience at either Sponsor or CRO.
- Strong track record for successful study execution.
- Advisory knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials.
- Experience in Finance Management, i.e. Budget Forecasting, Change Order Management, and Accruals.
- Experience working with EDC, CTMS, and eTMF systems.
- Strong interpersonal communication skills.
- Excellent cross-functional clinical project management skills.
- Must have exceptional leadership skills, including motivation and delegation.
- Record of supervisory experience, for each direct report there will be maintenance of retrospective and prospective vigilance of utilization, and employee satisfaction.
- Outstanding written communication skills including writing technical documents, such as protocols, protocol amendments, informed consent, investigator brochure, pharmacy manual and other trial-related documents.
- Ability to travel up to 30% domestic and international.
- Strong computer skills with Microsoft Office 365 (outlook mail, word processing, excel spreadsheet, project gantt, powerpoint), Zoom meetings, and document control management systems.
- Models our Core Values: is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.
- All Vaxcyte employees require vaccination against COVID-19.
Reports to: Vice President of Clinical Operations
Location: San Carlos, CA
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $195,000 - $201,000