Senior Director, Clinical Operations

2 days ago

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Vaxcyte

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Description

• Join our Mission to Protect Humankind! • Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines. • Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella. • WHAT we do is every bit as important as HOW we do it! • Our work together is guided by four enduring core values: RETHINK CONVENTION, AIM HIGH, LEAD WITH HEART, and MODEL EXCELLENCE. • The Sr. Director, Clinical Operations is responsible for initiating and leading high priority vaccine clinical programs across all phases. • This individual possesses clinical operations expertise with a track record of success. • The Sr. Director will be a leader in the organization who knows how to manage a team internally. • Will contribute to a high functioning mission driven team focused on patient safety, adherence to timelines, and data integrity.

Requirements

• BS/BA in Life Sciences or Nursing with a minimum of 16 years of relevant clinical trial experience in the pharmaceutical or biotech industry, including at least 8 years CRO management experience and 8 years of people management experience. Must have experience in vaccine clinical operations. • Strong track record for successful study execution in leading and managing global phase 1-3 clinical trials within designated timelines, resources, and budgets. Demonstrated ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking and reporting activities. • Comprehensive knowledge of industry practices, outsourcing, and GCP system requirements. • Strong understanding of clinical trial methodology and drug development process. • Strong knowledge of FDA Regulations, ICH Guidelines, GCP, and applicable regulatory requirements is required. Understanding of medical terminology is also required. • Excellent experience working with EDC, CTMS, and eTMF systems required. • Must have experience with vendor management and CRO oversight. • Excellent interpersonal and collaboration skills, with the ability to build effective relationships across departments. Effective in influencing and relationship-building. Strong analytical, negotiation, and persuasion skills. • Must be highly experienced in managing collaborations with CROs, vendors, and other external organizations, with prior experience in the implementation of global clinical trials. • Outstanding organizational skills with the ability to multi-task and prioritize and effectively manage several competing priorities and time sensitive business needs. • Outstanding written communication skills including writing technical documents, such as protocols, protocol amendments, informed consent, investigator brochure, pharmacy manual and other trial-related documents. • Outstanding verbal communication skills, including effective presentation skills to internal and external stakeholders at all levels. • Excellent cross-functional clinical project management skills. • Strong problem solving and decision-making skills. Exceptional organizational abilities with high attention to detail. • Experience in Finance Management, i.e. Budget Forecasting, Change Order Management, and Accruals. • Strong people management skills with experience managing direct reports, demonstrating effective teamwork, proven leadership, and hands-on coaching and management. • Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities. • Demonstrates critical and creative thinking, is resourceful and works proactively with initiative. Must be solutions driven with strong problem-solving skills. • Experience with regulatory authority inspections is a plus. • Highly proficient in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus. • Ability to travel up to 30% domestically and internationally. • Models our Core Values: is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.

Benefits

• Competitive compensation package includes comprehensive benefits and equity component.