Associate Director – Field Monitoring Operations

🕒 August 4

🇺🇸 United States – Remote

💵 $195.5k - $230k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

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ImmunityBio, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

ImmunityBio, Inc. is a biotechnology company focused on developing innovative immunotherapies to enhance the immune system's ability to fight cancer and infectious diseases. By harnessing the power of the body’s immune response, ImmunityBio aims to provide breakthrough treatments that can improve patient outcomes and longevity in challenging diseases.

📋 Description

• Lead the monitoring strategy, including Risk-Based Quality Management (RBQM) and Decentralized Clinical Trial (DCT) components, across the clinical trial portfolio • Safeguard data integrity, patient safety, and regulatory compliance • Lead remote Clinical Research Associates and Managers and mentor direct reports • Liaise with contract research organizations (CROs) and site investigators • Ensure trials follow protocols, SOPs, ICH GCPs, and applicable regulations • Design and oversee RBQM frameworks and modern data surveillance strategies aligned with ICH E6(R3) • Integrate remote, on-site, and decentralized monitoring with trial start-up, site activation, and study close-out • Optimize cross-functional study team operations, resource management, and study-team resourcing • Identify clinical operations process issues and lead best-practice and continuous-improvement initiatives • Provide quality oversight and contribute to inspection readiness • Own, review, revise, and delegate Clinical Operations SOP responsibilities • Contribute to strategic direction for multiple clinical studies • Provide training, mentoring, and review of study-specific documents • Share cross-team, site learnings, and best practices • Perform ad-hoc and cross-functional projects as assigned

🎯 Requirements

• Bachelor’s degree in life sciences, nursing, pharmacy, or a health-related field with 10+ years of progressive industry experience; or Master’s degree with 8+ years of progressive industry experience • 6+ years of management experience leading teams in clinical trial operations • Knowledge of clinical research, Good Clinical Practices (ICH E6(R3)), and regulatory requirements/guidelines • Expertise developing and managing Risk-Based Quality Management (RBQM) strategies • Proficiency interfacing with clinical research functions and driving cross-functional alignment • Excellent English verbal and written communication skills • Ability to maintain corporate confidentiality • Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook • Proficiency using Veeva Clinical Vault, CTMS, and eTMF • Ability to travel up to 75% based on study requirements • Ability to work flexible hours across various time zones • Ability to work in a standard office setting and use standard office equipment, including a computer

🏖️ Benefits

• Professional development opportunities • Discretionary bonus • Equity award • 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 • Employee Discounts, Rewards and Perks • Paid Time Off (PTO), including 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 • Health and Wellness tools and resources • Flexible work schedule with manager approval