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Senior Director, Global Clinical Data Management
ImmunityBio
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About this role
Company Overview 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. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.
Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. • Work with a collaborative team with the ability to work across different areas of the company. • Ability to join a growing company with professional development opportunities.
Position Summary The Senior Director, Global Clinical Data Management will provide strategic and operational leadership for all clinical trial data management activities across the global development portfolio. This role ensures delivery of high-quality, regulatory-compliant clinical datasets to support submissions, publications, and decision-making. The Senior Director will define enterprise-wide clinical data governance strategy and ensuring consistent, high-quality data across clinical development, real-world evidence, and digital health programs.
Essential Functions • Define and execute global Clinical Data Management (CDM) strategy across Phase I–IV clinical trials • 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 to ensure strong succession planning and talent retention. • Responsible for indirectly leading a team of Clinical Data Management Leaders in the planning, directing, and coordinating of all Clinical Data operations across the global segment. • Own talent management processes at the leadership level. • 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 (CROs, FSPs, external partners) ensuring delivery on time, within budget, and to quality standards • Oversee data quality, lineage, traceability, and audit readiness systems • Drive inspection readiness and regulatory audit support for clinical datasets • Lead modernization initiatives including automation, AI-enabled data review, and advanced clinical data platforms • Oversee Clinical Data Management budget planning, resource forecasting, and vendor contracts • Build and manage a high-performing Clinical Data Management team through hiring, developing, and providing performance feedback to subordinate managerial and professional talent • Collaborate within and across functional areas to evaluate, recommend, and implement process and technology improvement initiatives • Ensure compliance with GCP, SOPs, and regulatory expectations • Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.
Education & Experience • 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
Knowledge, Skills, & Abilities • 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) • Strong enterprise data governance experience • Expertise in multi-study portfolio management • Ability to understand, and interpret clinical data analytics and analyze outcomes • Excellent leadership skills with the ability to build a high-performing team and lead others effectively • Excellent project management skills with the ability to prioritize multiple tasks and objectives to consistently deliver to goals and timelines • Strong critical and logical thinking with ability to analyze problems, identify alternative solutions and implement recommendations for resolution
Working Environment / Physical Environment • This position works on-site or remotely depending on the candidate’s geographic location as noted in your offer letter. • Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval • This position works in an office environment and requires regular use of computer keyboards and sitting for extended periods of time
This position is eligible for a discretionary bonus and equity award. The annual base pay range for
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