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Manager, Global Clinical Programs

3 months ago


El Segundo, United States ImmunityBio Full time

ImmunityBio, Inc. is a late-stage immunotherapy company developing a broad pipeline of next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company’s immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.” The U.S. Food and Drug Administration (FDA) has accepted for review ImmunityBio’s resubmission of its Biologics License Application (BLA) for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease, and has set a user fee goal date (PDUFA date) of April 23, 2024.

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 an early-stage public biopharmaceutical company with a headquarters in Southern California.
- Work with a collaborative team with the ability to work across different areas at the company.
- Ability to join a growing company with development opportunities.

Position Summary

The Manager, Global Clinical Programs (MGCP) will serve as the clinical operations leader in an assigned therapeutic program. This individual will be responsible for implementing the company’s goals and priorities as they relate to the assigned therapeutic program. The MGCP must be effective in leading clinical research staff as well as being accountable to the highest levels of management. They will be an expert with regards to the clinical operations and status of the assigned therapeutic program. This is a highly visible role within the company.

Essential Functions
- Lead a team of Clinical Trial Managers, Clinical Research Associates and Clinical Trial Associates to meet the goals and timelines of the assigned therapeutic program.
- Act as the representative for program’s global clinical operations to functional group leaders, external vendors, and senior management.
- Partner effectively and synergistically with stakeholders across the entire company
- Manage, train and mentor Clinical Trial Managers on day-to-day activities and strategic initiatives.
- Performs other special projects and duties as assigned.

Education & Experience
- Minimum of Bachelor’s degree in science (Master’s or PhD preferred)
- At least 7 years of experience working as a Clinical Trial Manager or Clinical Program Manager
- Experience with feasibility, project, budget, and resource management.
- Global experience managing Clinical Research Organizations (CROs), central labs and other vendors required
- Previous people management experience.
- Previous experience working in a dynamic and fast-paced environment.
- Comfortable working directly with the highest levels of the company.
- Experience in NDA submissions, experience with BLA submissions is ideal.
- Strong background in oncology clinical development

Knowledge, Skills, & Abilities
- Demonstrated ability working directly with the highest levels of the company with ease
- Excellent verbal and written communication skills in English
- Knowledge of FDA guidelines as well as ICH/GCP Guidelines.
- Deep understanding of the drug development process and prior experience in the biopharmaceutical industry.
- Excellent time
- and project-management skills, attention to detail, and ability to balance multiple projects simultaneously
- Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution
- Ability to work collaboratively in a dynamic environment
- Ability to mentor and develop junior employees within the assigned therapeutic program and more broadly across the clinical operations organization
- Highly proficient in, MS Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, eTMF, CTMS, and eCTD authoring templates
- Maintain corporate confidentiality at all times.

Working Environment / Physical Environment
- This position will work on site
- Ability to work flexible hours for various time zones (management located in Southern California)
- Ability to travel as needed on a limited basis

$166,000 (entry-level qualifications) to $190,000 (highly experienced)

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 -