Clinical Trial Manager, Clinical Operations
Vaxcyte
Operations
San Carlos, CA, USA
Posted on Wednesday, August 2, 2023
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:
Reporting to the Senior Director of Clinical Operations, the Clinical Trials Manager (CTM) will be responsible for assisting in the planning, managing, resourcing, training, and delivering all clinical operations aspects of a study with guidance from Senior Director and Vice President of Clinical Operations. Expected activities include the successful oversight and management of Contract Resource Organization(s), vendors, study teams, and investigative site personnel under the direction of a senior level clinical operations lead. The CTM will manage the conduct of clinical trial activities in accordance with contractual agreements, Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials.
Essential Functions:
- Manage defined aspects of clinical trials to ensure assigned trials are completed on time according to corporate goals and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.
- Collaborate with the Study Management Team and Senior Clinical Operations Lead to ensure transparent and proactive internal and external communication regarding study progress, trial issues and resolution.
- Perform the activities associated with the implementation and monitoring of clinical trials such development of clinical protocols, informed consent forms, pharmacy manual, laboratory manual, investigational plans, study materials (e.g., training materials, case report forms, study files, supplies requirements).
- Work with Senior Director, Clinical Operations and Medical Monitor to assist with selection of investigative sites, train investigators and investigative site staff, and prepare materials for investigator meetings. The outsourcing model is intended to oversee CRO personnel contracted to perform these services, but in some cases, Vaxcyte may take responsibility.
- Develop and maintain detailed study timelines using MS Project or SmartSheet including identifying and communicating trial issues that will impact budget, resources and/or timelines.
- Collaborate with Finance to adhere to the contractual and budgetary obligations of the clinical trial overseen by the Director of Clinical Budgets and Contracts and Finance.
- Lead vendor oversight activities across all vendors within one or multiple studies within designated programs with guidance from Senior Director or Vice President of Clinical Operations.
- Includes review of study plans inclusive of but not limited to monitoring plan, protocol deviations, communication, laboratory manual, etc.) and invoices accuracy compared to vendor contract; and will aid in the development of technical specifications for vendors (e.g. scope of work).
- Perform co-monitoring field assessment visits periodically to assess GCP/ICH knowledge and compliance in practice and to ensure continued level of optimal performance.
- Provide training by implementing effective orientation and mentoring for junior clinical study team members.
- Initiate process improvement work streams to develop efficiencies and expand Clinical Operations Department’s footprint.
- Assist in creating and implementing departmental procedures in compliance with industry standards and regulatory requirements.
- Be an outstanding teammate.
Requirements:
- BS/BA in Life Sciences or related discipline
- CTM is a minimum of 4+ years industry drug, biologic, vaccine development experience; 1+ years’ experience in assisting in management of clinical trials, preferably in a small biotech environment.
- Thorough knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials.
- Proven experience in building relationships with cross functional project team, and key external stakeholders (CRO, vendors and medical personnel at clinical sites) to achieve clinical trial goals.
- Providing performance feedback on junior clinical personnel for annual appraisals.
- Proficiency with electronic databases (EDC, IWRS, Central Lab, CTMS) and filing (archiving) systems.
- Demonstrated problem solving abilities and strong organizational skills.
- Must be self-motivating, prioritize and manage a large volume of work, and show attention to detail.
- Passion to learn, high integrity, and strong work ethic.
- Strong interpersonal skills with reputation for collaboration with colleagues.
- 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 must be vaccinated against COVID-19.
Reports to: Senior Director, Clinical Operations
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $155,000 – $180,000
Vaxcyte, Inc.
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.