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 interpersonal skills.

• Ability to maintain corporate confidentiality at all times.

• Proficiency in MS Office including Word, Excel, PowerPoint, and Outlook.

• Proficient with use of Veeva Clinical Vault, CTMS, and eTMF.

Working Environment / Physical Environment

• This position works remotely.

• Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval.

• Must be able to travel up to 75% of the time based on study requirements

• Ability to work flexible hours across various time zones

• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

National Market (all markets unless identified as Premium)

$195,500 (entry-level qualifications) to $215,000 (highly experienced) annually

Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston)

$210,000 (entry-level qualifications) to $230,000 (highly experienced) annually

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

ImmunityBio uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.

Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: 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) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day •  We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.