Associate Director, Field Monitoring Operations

About this role

Company Overview
ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.

Why ImmunityBio?
• ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
• Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
• Work with a collaborative team with the ability to work across different areas of the company.
• Ability to join a growing company with professional development opportunities.

Position Summary
The Associate Director, Field Monitoring Operations is responsible for designing, implementing, and overseeing the monitoring strategy, including Risk-Based Quality Management (RBQM) and Decentralized Clinical Trial (DCT) components that safeguard data integrity, patient safety, and regulatory compliance across the organization’s clinical trial portfolio. This role anchors the monitoring function within the broader development pipeline, ensuring that study execution aligns with both internal SOPs and external regulatory expectations. The Associate Director will lead a cross‑functional team of remote Clinical Research Associates and Managers, fostering a culture of continuous improvement and operational excellence. In addition, the Associate Director will act as a primary liaison with external contract research organizations (CROs) and site investigators, translating strategic objectives into actionable monitoring plans that drive timely and high‑quality data capture.
Essential Functions

• Provide leadership to team members and study teams to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), ICH Good Clinical Practices (GCPs), and other applicable regulatory requirements as well as management and mentoring of direct reports.

• Design, implement, and oversee Risk-Based Quality Management (RBQM) frameworks and modern data surveillance strategies across the clinical portfolio, ensuring alignment with ICH E6(R3).

• Integrate monitoring activities (including remote, on-site, and decentralized trial approaches) with trial start‑up, site activation, and study close‑out processes, thereby creating a seamless end‑to‑end operational flow.

• Utilize negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional study team partnership and to ensure effective in-house clinical study team operations.

• Directly participates in and contributes to cross-functional and functional teams to discuss, review, and optimize resource management strategy.

• Collaborate with trial execution leadership to ensure optimal resourcing of the study teams.

• Anticipate potential clinical operations process issues and influence and collaborate with the organization in adopting best practices, making recommendations for improvements, or leading development of new processes and continuous improvement of existing processes, tools, reports, and systems.

• Provide quality oversight of trial operations to contribute to inspection readiness.

• Own Clinical Operations Standard Operating Procedures (SOPs), responsible for review and revision or delegating duties as needed, specifically integrating modern risk-management frameworks.

• Contribute to the development and implementation of strategic direction in the conduct of multiple clinical studies.

• Provide management support to the clinical operations team across all trials/programs by way of training, mentoring or review of study specific documents as needed.

• Collaborate with colleagues to ensure cross-team, site learnings, and best practices are shared.

• Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities.

Education & Experience

• Bachelor’s degree in life sciences, nursing, pharmacy or health-related field. (Master's degree preferred) with 10+ years of progressive industry experience required; or

• Master’s degree with 8+ years or progressive industry experience required.

• 6+ years management experience leading teams in clinical trial operations required.

• Previous experience working in a dynamic and fast-paced environment is preferred.

Knowledge, Skills, & Abilities

• Effective leadership skills with the ability to promote a culture of collaboration and competence for direct and indirect reports.

• Strong knowledge of clinical research, Good Clinical Practices (ICH E6(R3)), and regulatory requirements/guidelines.

• Proven expertise in developing and managing Risk-Based Quality Management (RBQM) strategies.

• Proficiency in interfacing with other functions in clinical research and driving cross-functional alignment.

• Excellent English verbal and written communication skills; good organizational and…