Senior Director, Global Clinical Data Management

🕒 Julho 21

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ImmunityBio, Inc.

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

🏥 Saúde

💼 Consultoria

🏭 Manufatura

Healthcare • Consulting • Manufacturing

A ImmunityBio, Inc. é uma empresa de biotecnologia focada no desenvolvimento de imunoterapias inovadoras para aprimorar a capacidade do sistema imunológico de combater o câncer e doenças infecciosas. Ao aproveitar o poder da resposta imune do corpo, a ImmunityBio visa fornecer tratamentos revolucionários que possam melhorar os resultados e a longevidade dos pacientes em doenças desafiadoras.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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