Associate Director, Clinical Data Management
San Carlos, CA, USA
Posted on Saturday, July 29, 2023
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.
This is an exciting opportunity to grow the Vaxcyte, Clinical Data Management (CDM) Team. This is a hands-on position that will expand over time to include supervising additional CDM resources at Vaxcyte, based on the number of clinical trials in development. The Associate Director, Clinical Data Management (ADCDM) will be responsible for the oversight and management of our Biometrics partners related activities conducted for clinical trials conducted by Vaxcyte, from study start-up through to study closeout, ensuring high quality data deliverables which are on time and within budget.
- 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 (e.g., 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 on boarding of new DM team members.
- Bean outstanding teammate.
- 8-10+ years of data management experience in a biopharmaceutical company or CRO with duties of varying complexity.
- Bachelor's Degree in a scientific, technical or health related field.
- Knowledge of clinical data management principles, regulations, CDISC, GCDMP 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.
- Vendor oversight experience in Clinical Data Management.
- 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: Director, Clinical Data Management
Location: San Carlos, CA
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $180,000 - $196,000
Send resumes to:
825 Industrial Road, Suite 300
San Carlos, CA 94070
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.