Director, Field Monitoring Operations

📋 Description

• • As the Director, Field Monitoring Operations at ImmunityBio, you will be instrumental in shaping and executing the company's clinical trial monitoring strategy. This pivotal role is responsible for ensuring the integrity of clinical trial data, the safety of study participants, and unwavering adherence to regulatory standards across our diverse portfolio of clinical studies.
• • You will anchor the critical monitoring function within the broader clinical development pipeline, ensuring that all study execution activities are meticulously aligned with both internal Standard Operating Procedures (SOPs) and stringent external regulatory expectations. Your leadership will be key to maintaining the highest standards of quality and compliance.
• • This position offers the unique opportunity to lead and mentor a geographically dispersed, remote team of Clinical Research Associates (CRAs). You will foster a dynamic environment that champions continuous improvement, operational excellence, and a shared commitment to scientific advancement.
• • A significant aspect of your role will involve serving as a primary liaison with external Contract Research Organizations (CROs) and clinical site investigators. You will translate high-level strategic objectives into detailed, actionable monitoring plans that are designed to drive the timely capture of high-quality, reliable data.
• • You will provide essential leadership and guidance to your direct reports and broader study teams, ensuring that all clinical trials are conducted in strict accordance with approved protocols, established SOPs, Good Clinical Practices (GCPs), and all other applicable regulatory requirements. This includes robust management and mentorship of your team.
• • You will be responsible for seamlessly integrating monitoring activities with the critical phases of trial start-up, site activation, and study close-out. This integrated approach will create a smooth, end-to-end operational flow, minimizing delays and maximizing efficiency.
• • Leveraging your strong negotiation, facilitation, meeting management, and conflict resolution skills, you will enhance cross-functional study team partnerships and ensure the effective operation of in-house clinical study teams.
• • You will actively participate in and contribute to cross-functional and functional team discussions, focusing on the review and optimization of resource management strategies to ensure optimal allocation and utilization.
• • Collaborate closely with trial execution leadership to guarantee that study teams are optimally resourced, enabling them to meet and exceed project milestones.
• • Proactively anticipate potential clinical operations process issues. You will influence and collaborate with the wider organization to adopt best practices, making informed recommendations for improvements, or taking the lead in developing new processes and continuously enhancing existing ones, tools, reports, and systems.
• • Provide comprehensive quality oversight of trial operations, making a significant contribution to the organization's inspection readiness and ensuring a state of constant preparedness.
• • You will own the Clinical Operations Standard Operating Procedures (SOPs), taking responsibility for their thorough review, revision, or the effective delegation of these duties as required.
• • Contribute significantly to the development and implementation of the strategic direction for the conduct of multiple clinical studies, ensuring alignment with company goals.
• • Offer management support to the clinical operations team across all trials and programs through dedicated training, mentorship, and the review of study-specific documents as needed.
• • Foster a culture of knowledge sharing by collaborating with colleagues to ensure that cross-team learnings and best practices are effectively disseminated throughout the organization.
• • Undertake ad-hoc and cross-functional duties and/or projects as assigned, supporting broader business needs and providing valuable developmental opportunities for yourself and others.