Essential Functions:

• Lead and oversee the strategic planning, implementation and execution of clinical trials across key vaccine programs in accordance with project timelines, budget, and quality standards.
• Implementation of clinical strategy including site selection, study start up, authoring/reviewing study documents (protocols, informed consent forms, clinical study reports, site facing material, etc.), monitoring study status across internal functions and external vendors, anticipating and mitigating risks within the timeline, quality, and study budget.
• Collaborate with Clinical Outsourcing team for evaluation and selection of CROs/vendors, including ongoing management to ensure successful clinical trial implementation and execution. In addition, collaborating with Legal to review contracts and amendments for CROs/vendors, and support negotiations of terms and budgets if needed.
• Develop and manage comprehensive program project plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies.
• Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs, Biostatistics, Clinical Data Management, Clinical Supplies, Manufacturing, Clinical Outsourcing and Program Leadership to ensure alignment on clinical trial objectives and milestones in accordance with state/federal regulations, GCP, ICH and internal SOPs.
• Clinical QC: Support the development of quality control processes and study plans to ensure that clinical activities are compliant with GCP and regulatory guidelines. Ensure execution of trials according to the study protocol and procedures, SOPs, ICH/GCP, FDA, EMEA, NICE, and other relevant policies and regulations.
• Supply Chain Management: Liaise with the supply chain function for supply of vaccines to clinical sites.
• Clinical Study Execution: Management of all clinical operations support vendors contracted for the assigned studies, including budgets and timelines oversight, performance management, risk management, and issue resolution.
• Clinical Study Team Meetings: Lead team meetings, as assigned, both internally and with multiple vendors. Attend project team and/or Executive team meetings, as required.
• Clinical Study Site Management: Cultivate and maintain strong relationships with investigators and trial site administrators. Organize investigator meetings as needed and contribute to the development of abstracts, presentations, and manuscripts for studies. Serve as the point of contact for Executive Governance with CROs and vendors, overseeing their performance and ensuring adherence to contractual agreements, timelines and quality standards.
• Clinical Trial Budgeting: Leads the creation of initial study budgets with input from cross functional leads and acts as the primary point of contact with finance and leadership team throughout the life of the study. Maintain oversight of clinical operations budget, including regular forecasting and internal reporting to management and finance. Review vendor invoices against the scope of work, work completed to date and identify and communicate discrepancies.
• Provide operational expertise and strategic input into the development of Clinical Development Plans (CDP), supporting the overall clinical strategy for the program.
• Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct.
• Oversee and manage the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Clinical Data Management teams to ensure data accuracy and integrity.
• Contribute to the preparation and review of clinical study documents including the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, applicable sections of Biologics License Applications (BLA) and or Marketing Authorization Application (MAA), updates to the IND, NDA and other safety reports.
• Develop and implement processes across operations functions to ensure proactive inspection readiness.
• Collaborate with Clinical Quality Assurance on and oversee inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct.
• Provide leadership to study teams & make recommendations in strategic aspects of clinical program. Represent Clinical Operations on cross-functional program teams and vendor/CRO operational meetings.
• Ensure consistency in processes and drive Clinical Operations performance and adherence to clinical trial project timelines.
• Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance.
• Lead in clinical operations workstreams related to departmental and operating model related initiatives.
• In collaboration with the Head of Clinical Operations, hire, manage, train and develop the Clinical Operations team, fostering a culture of collaboration, accountability, continues improvement, and operational excellence.
• Develop and foster strong, collaborative relationships with key stakeholders both within and external to Vaxcyte.

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 interna and external stakeholders at all levels.
• Excellentcross-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.