Associate Director, Central Monitoring

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, Central Monitoring Unit (CMU) Lead will serve as the primary architect and operational leader of the company's Risk-Based Quality Management (RBQM) strategy. This role acts as the execution arm for central data surveillance and will transition the organization from traditional 100% data review to a proactive, critical-thinking model. This role will chair the Clinical Data Quality and Governance Board (CDQGB) and ensure all central monitoring activities align with global regulatory expectations (ICH E6(R3)).

Essential Functions

• Design, implement, and oversee the CMU operational framework, ensuring seamless integration with existing Field Monitoring operations.

• Lead and chair the Clinical Data Quality and Governance Board (CDQGB), driving cross-functional consensus on risk thresholds (QTLs/KRIs).

• Act as the primary process owner for all CMU-related SOPs, Work Instructions, and Risk Assessment and Categorization Tools (RACT).

• Manage the integration of multi-vendor data streams (EDC, CTMS, RTSM, eCOA, Safety DB) into a centralized surveillance engine (e.g., Veeva RBM).

• Act as the ultimate escalation point for systemic issues identified by central monitors, partnering with Clinical Operations to execute targeted mitigation.

• Drive the cultural shift across Data Management and Biostatistics to adopt risk-based, Critical-to-Quality (CtQ) focus over administrative data review.

• Manage, coach, and evaluate a team of Central Monitors.

• 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 a clinical research, science, or health-related field required (Master's degree preferred)

• 8+ years of progressive experience in clinical research (Clinical Operations, Data Management, or Biostatistics), with domestic and international clinical trials experience required.

• 3+ years of direct experience implementing or managing Risk-Based Quality Management (RBQM) frameworks required

• Prior supervisory and department-building experience required.

Knowledge, Skills, & Abilities

• Deep expertise in ICH GCP E6(R3) and global regulatory expectations (FDA, EMA, MHRA) regarding risk-based monitoring.

• Strong critical and logical thinking with the ability to "investigate" data signals that don't have a clear answer on day one.

• Excellent cross-functional leadership skills; ability to influence Medical Monitors, Biostatisticians, and Data Managers.

• Proficient in interpreting clinical data dashboards, visualizations, and KRI/QTL reports.

• Knowledge of modern clinical systems, specifically Veeva Vault (CDMS, CTMS, RBM, QMS).

• Ability to maintain corporate confidentiality at all times.

Working Environment / Physical Environment