Senior Director, Global Clinical Data Management

Posted 2 Days Ago
Be an Early Applicant
Hiring Remotely in USA
Remote
230K-280K Annually
Senior level
Healthtech • Biotech
The Role
Lead global clinical data management strategy and operations across Phase I-IV trials. Oversee CRF design, database builds, edit checks, data quality, governance, vendor/CRO relationships, regulatory inspection readiness, modernization (automation/AI), budgeting, and talent development to deliver regulatory-compliant clinical datasets.
Summary Generated by Built In

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.

Skills Required

  • Bachelor's or Master's degree in life sciences or technical discipline
  • 12+ years clinical data, clinical operations, or healthcare data systems experience
  • Strong enterprise data governance experience
  • Experience developing and managing direct and indirect reports
  • Experience managing a global team
  • Deep knowledge of EDC systems
  • Deep knowledge of CDMS platforms
  • SDTM/CDISC standards
  • Working knowledge of clinical research, GCP, FDA, EMA, and ICH guidelines
  • Strong regulatory inspection experience (FDA/EMA)
  • Expertise in multi-study portfolio management
  • Experience leading modernization initiatives including automation and AI-enabled data review
  • Strong leadership and project management skills, including budgeting and vendor oversight
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: El Segundo, CA
547 Employees

What We Do

ImmunityBio, Inc. (formerly NantKwest, Inc.) is 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. The activation of the innate immune system is key to the development of immunological memory. Over the last two decades, our founder and Executive Chairman Dr. Patrick Soon-Shiong has investigated mechanisms to activate the immune system to attack tumors that can otherwise evade and escape the body’s defense mechanisms. After inventing the world’s first protein nanoparticle drug, Abraxane, Dr. Soon-Shiong turned his focus to the next generation of immunotherapies. ImmunityBio was founded in 2014 to create innovative immunotherapies that address serious unmet needs in oncology and infectious diseases. "At ImmunityBio, we envision a day when we no longer fear cancer but are able to conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop remarkable new 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." -Dr. Patrick Soon-Shiong, Executive Chairman

Similar Jobs

Dragos Logo Dragos

Senior Customer Success Manager

Security • Cybersecurity
Remote
United States
295 Employees
140K-140K Annually

Pfizer Logo Pfizer

Director, Site Management & Monitoring

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
In-Office or Remote
2 Locations
121990 Employees
177K-294K Annually

Applied Systems Logo Applied Systems

Senior Product Manager

Cloud • Insurance • Payments • Software • Business Intelligence • App development • Big Data Analytics
Remote or Hybrid
United States
3079 Employees
100K-180K Annually

Applied Systems Logo Applied Systems

Data Engineer

Cloud • Insurance • Payments • Software • Business Intelligence • App development • Big Data Analytics
Remote or Hybrid
United States
3079 Employees
70K-120K Annually

Similar Companies Hiring

Sailor Health Thumbnail
Healthtech • Social Impact • Telehealth
New York City, NY
20 Employees
Granted Thumbnail
Artificial Intelligence • Healthtech • Insurance • Mobile • Financial Services
New York, New York
23 Employees
OneImaging Thumbnail
Healthtech
Miami, FL
62 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account