Manager, Regulatory Lifecycle Maintenance

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 Manager, Lifecycle Maintenance will advance the maintenance global clinical regulatory compliance for investigational and marketed products and manage the maintenance of study files in eCTD format. This position will contribute to the organization in the design and conduct of clinical trials in conformance with Health Authority requirements and the management of clinical trial documentation to support clinical submissions.

Essential Functions

• Lead Lifecycle Maintenance staff by delegating projects, establishing and meeting timelines, and ensuring high quality work products
• Manage the day-to-day activities of staff to include the hiring and training of new team members, coaching employees and monitoring performance.
• Provide input to the design and reporting of clinical studies performed by IBRX or by CROs
• Manage the review, cataloguing, and submission of documents including investigator brochures, protocols, informed consent forms, clinical study reports, annual reports, DSURs, PSURs, PAERs, and clinicaltrials.gov entries in the US and abroad
• Manage all protocol supportive documentation including the cataloguing and submission of essential investigator qualification documents
• Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan
• Create and maintain project plans for regulatory lifecycle maintenance operations
• Monitor FDA and other healthauthority guidance, prepare supplemental dossiers, and manage the lifecycle documentation for postapproval changes.
• Lead datadriven strategic initiatives to maintain comprehensive regulatory documentation, ensuring compliance and supporting organizational objectives.
• Oversee configuration, maintenance, and user support for internal platforms used for file storage.
• Participate in cross-functional teams and provide support to others in the preparation, analysis, and documentation of studies
• Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications
• Manage the internal review of the relevant clinical sections of written summaries for regulatory submissions including INDs, NDAs, and BLAs
• Performs ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities.

Education & Experience

• Bachelor's Degree in life sciences or technical discipline with 7+ years relevant progressive experience required; or
• Master's degree in life sciences or technical discipline with 5+ years relevant progressive experience required; or
• Doctorate degree in life sciences or technical discipline with 3+ years relevant progressive experience required
• Experience managing staff preferred
• Experience in the management and preparation of the submission of clinical modules in eCTD format required
• Experience with organizing responses to Health Authority information requests required
• Familiarity with global regulatory submissions (US and ex-US) strongly preferred

Knowledge, Skills, & Abilities

• Strong knowledge of Health Authority guidance documents and requirements
• Strong leadership skills with the ability to direct and develop professional staff
• Strong knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
• Strong organizational skills, written and oral communication skills, and attention to detail

Working Environment / Physical Environment

• This position works on site in Summit, NJ.
• Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval
• This position may need to sit for long periods of time and use various computer programs
• This desk-based role involves the close study of scientific and regulatory documents
• This position will work closely with scientific colleagues throughout the day, often on a project-team basis

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.

$165,000 (entry-level qualifications) to $181,000 (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 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.