Clinical Operations

• Define and implement short- and long-term clinical operations strategies across cell therapy franchises
• Develop therapeutic operating models, country footprints, site strategies, and operational clinical development plans
• Provide strategic oversight of global cell therapy clinical studies, delivering on time and cost while meeting quality and regulatory standards
• Participate in enterprise cell therapy governance and provide Protocol Review Committee sign-off for clinical operations
• Conduct operational reviews ahead of key decision bodies, including DRC and ESPC/LSPC
• Establish and communicate delivery strategies, portfolio priorities, and key metrics to leadership
• Partner with planning leaders on slot forecasting and prioritization decisions
• Ensure preparation for regulatory submissions and sustained inspection readiness
• Build, inspire, and lead a capable global team across program leadership roles
• Set vision and strategy, elevate performance, and develop capabilities at scale
• Lead financial cycle planning, including MTP, LTP, phased budgets, training, onboarding, and functional budget management
• Build partnerships with Data Management, Vendor Management, Lab Management, Logistics, and Manufacturing functions
• Engage industry leaders to bring innovation into clinical operations practice
• Lead large transformational workstreams within and beyond the function
• Serve as a key leadership team member shaping the forward plan and standardizing delivery across programs
• Scale and align a 50+ person global team across five countries and shared functions

Executive Director, Clinical Operations – Program Management

• Lead global investigations and support teams with CAPA preparation in compliance with applicable regulations/guidelines, customer requirements, SOPs and project-specific guidelines/instructions.
• Manage Quality Issues and serious breach investigations.
• Review and approve Investigations, Root Cause Analysis, CAPA and Effectiveness Check plans.
• Track quality events from Quality Issues, Audits, Inspections and similar QA activities until closure.
• Manage and oversee quality event updates in eQMS.
• Plan, schedule and conduct risk-based and For Cause audits of clinical investigator sites, CROs and other GCP vendors.
• Support regulatory agency inspection readiness, including mock inspections, gap assessments and inspection response coordination.
• Evaluate policies and procedures for regulatory compliance and recommend continuous process improvements.
• Support QA initiatives and process improvement projects.
• Promote a quality mindset and quality excellence across activities.
• Interpret regulatory agency policies and guidance related to GCP requirements and assist with implementing compliant processes at Vaxcyte.
• Report to the Senior Director, Clinical Quality Assurance.

Senior Manager, Clinical Quality Assurance

• Lead and deliver global Phase 1-4 clinical trials
• Lead early development studies, including FIH/SAD/MAD and other early-phase designs
• Own end-to-end operational strategy and execution for developmental programs across studies and geographies
• Develop and maintain integrated study plans
• Participate in designing, implementing, and reviewing clinical protocols and study reports
• Ensure milestones are met with quality, attention to detail, and risk mitigation
• Select CROs, clinical pharmacology units, and key vendors
• Build governance and oversight models for accountability, performance, and predictable delivery
• Identify, qualify, manage, and maintain relationships with clinical trial sites and Principal Investigators
• Support robust protocols, site selection, patient recruitment, and enrollment targets
• Partner with Clinical Development, Safety, Regulatory, Biometrics, Clinical Supply, CMC, and Translational stakeholders
• Drive country/site feasibility, study start-up, vendor management, enrollment execution, data quality, TMF and inspection readiness, closeout, and timely study execution
• Deliver high-quality clinical study data and present results to cross-functional teams and external stakeholders
• Navigate ambiguity, identify problems, propose options, make decisions, and unblock teams
• Establish and improve clinical operations processes, templates, and metrics
• Contribute to pipeline growth, operational diligence, and integration planning
• Maintain advanced knowledge of the therapeutic area, product, clinical trial setting, literature, competitive intelligence, and treatment paradigms
• Own team role training and collaborate with Quality Assurance on GxP-compliant training
• Lead or assist in writing, reviewing, and approving clinical project deliverables, submissions, monitoring plans, CRFs, data management plans, safety plans, charters, closeout plans, inspection readiness plans, and CSRs

Clinical Operations jobs in California

Executive Director, Clinical Operations – Program Management

Senior Manager, Clinical Quality Assurance

Senior Director, Clinical Operations