Senior Director, Global Clinical Data Management

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ImmunityBio, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

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

• Provide strategic and operational leadership for all clinical trial data management activities across the global development portfolio • Ensure delivery of high-quality, regulatory-compliant clinical datasets to support submissions, publications, and decision-making • Define enterprise-wide clinical data governance strategy and ensure consistent, high-quality data across clinical development, real-world evidence, and digital health programs • Lead end-to-end data management operations including CRF design, database build, edit check strategy, and database lock • Responsible for the oversight of the Clinical Data Management team • Lead and mentor the leadership team in the development and improvement of skills, knowledge and abilities • Ensure effective quality, efficiency, and timeliness of data management projects through appropriate resource allocation and work prioritization • Establish global data standards, governance frameworks, and quality systems aligned with GCP, FDA, EMA, and ICH guidelines • Oversee clinical data vendors ensuring delivery on time, within budget, and to quality standards • Drive inspection readiness and regulatory audit support for clinical datasets • Collaborate within and across functional areas to evaluate, recommend, and implement process and technology improvement initiatives

🎯 Requirements

• Bachelor’s or Master’s degree in life sciences or technical discipline required • 12+ years of clinical data, clinical operations, or healthcare data systems experience required • Strong enterprise data governance experience required • Experience developing and managing a team direct and indirect reports required • Experience managing a global team strongly preferred • Deep knowledge of EDC systems, CDMS platforms, SDTM/CDISC standards • Working knowledge of the clinical research, Good Clinical Practices, and regulatory requirements/guidelines • Strong regulatory inspection experience (FDA/EMA) • Expertise in multi-study portfolio management • Ability to understand, and interpret clinical data analytics and analyze outcomes • Excellent project management skills with the ability to prioritize multiple tasks and objectives to consistently deliver to goals and timelines

🏖️ 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) 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