Associate Director, Central Monitoring

About the Company

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. ImmunityBio is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies designed to sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates aim to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.

ImmunityBio is a publicly traded company headquartered in Southern California, offering opportunities to work with a collaborative team and join a growing organization with professional development prospects.

About the Role

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. The role involves chairing the Clinical Data Quality and Governance Board (CDQGB) and ensuring all central monitoring activities align with global regulatory expectations (ICH E6(R3)).

Responsibilities

• 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 a 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 to support business needs and provide developmental opportunities.

Requirements

• 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.
• 3+ years of direct experience implementing or managing Risk-Based Quality Management (RBQM) frameworks.
• Prior supervisory and department-building experience.

Skills

• 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 lack immediate clarity.
• 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.

Schedule

• This position works remotely.
• Regular work schedule is Monday - Friday, within standard business hours, with flexibility available upon manager approval.
• Must be able to travel up to 20% of the time for internal team meetings or conferences.
• Ability to work flexible hours to accommodate various time zones.

Pay

The annual base pay range for this position is:

• National Market (all markets unless identified as Premium): $195,500 (entry-level qualifications) to $215,000 (highly experienced) annually.
• Premium Market (Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston): $210,000 (entry-level qualifications) to $230,000 (highly experienced) annually.

This position is eligible for a discretionary bonus and equity award. The specific rate will depend on the successful candidate’s qualifications, prior experience, and geographic location.

Benefits

• Medical, Dental, and Vision Plan Options
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• Healthcare and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance, and Employee Discounts, Rewards, and Perks
• Paid Time Off (PTO) including:
  • 11 Holidays
  • Exempt Employees: Unlimited PTO
  • Non-Exempt Employees: 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days, and 1 Cultural Day