Director, Clinical Data Management

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 (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 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 100 employees and anticipates continued, significant growth. On January 6, 2022, Vaxcyte announced that the U.S. Food and Drug Administration (FDA) had cleared the Investigational New Drug (IND) application for VAX-24, its lead vaccine candidate. The Company expects to initiate the VAX-24 Phase 1/2 clinical proof-of-concept study in adults in the first quarter of 2022 and announce Phase 2 topline immunogenicity, safety and tolerability results by the end of the year. VAX-24 was designed to prevent 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 is an exciting opportunity to define Data Management (DM) outsourcing strategies and data standards to be used across a clinical development program. This is a hands-on position that will expand over time to include hiring additional DM resources at Vaxcyte, based on the number of clinical trials in development. The Director, Clinical Data Management (DCDM) will be responsible for the oversight and management of all DM related activities conducted by Vaxcyte, from study start-up through to study closeout, ensuring high quality data deliverables which are on time and within budget. 
Essential Functions:

• Establishes and drives DM strategy related to outsourcing, data standards, technologies and processes to maximize efficiency, innovation and data quality.
• Reviews and manages CRO partners contracts and budgets, and assists with forecasting and accruals with Finance.
• Ensures DM deliverables provided by CRO partners meet/exceed project/study team expectations regarding quality, time and cost.
• Ensures DM documentation is filed/archived according to applicable company and regulatory requirements.
• Provides oversight for DM CROs and other third-party vendors who provide clinical study data to ensure compliance with the protocol, external/internal procedural standards, GCP, applicable regulatory guidelines, company policies, SOPs and other relevant guidelines.
• Acts as the primary liaison with DM CROs, third party vendors and EDC vendors for study work.
• Reviews clinical study related documents from a data management perspective (e.g. protocol) and approves DM specific documents (e.g. Data Management Plan, Data Review Plan, CRF Completion Guidelines, etc.).
• Assist clinical study team with the planning, preparation, and on-site support of investigators meetings and CRA trainings.
• Assist with tracking of status of DM related activities (eg. EDC setup, data cleaning, coding, etc.).
• Assist with final sign off of project and study-related documents including: Edit Check Specifications, CRF Completion Guidelines, Data Transfer Agreements, etc. 
• Coordinate and participate in team meetings/teleconferences/Zoom including preparation of agendas, minutes and tracking action items.
• Support onboarding of new DM team members.
• Author DM SOPs as needed.
• Be an outstanding teammate.

Requirements:

• 10-15+ years of data management experience in a biopharmaceutical company or CRO.
• Bachelor's Degree in a scientific or health related field.
• Knowledge of clinical data management principles, regulations CDISC, and best practices, as well as common software products and technologies used in drug development.
• Good knowledge of FDA and ICH regulations and industry standards applicable to drug development systems.
• Knowledge of regulations and best practices related to data collection, electronic records and signatures and data privacy.
• Leadership experience in Clinical ata Management leading a small to medium team and influencing executive-level management and key stakeholders.
• Travel to Vaxcyte San Carlos Headquarters approximately once per quarter and/or for critical meetings.
• ·All Vaxcyte employees require vaccination against COVID-19.

Reports to: Chief Medical Officer
 
Location: Remote
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.