全球临床数据管理高级总监

Company Overview
ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient’s immune system and treat the host rather than just the disease.
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 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)
$230,000 (entry-level qualifications) to $253,000 (highly experienced) annually
Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston)
$260,000 (entry-level qualifications) to $280,000 (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.
We are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.
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.
At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
Originally posted on Himalayas