Associate Director, Health Authorities

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 Associate Director, Health Authorities will aid the advance of global clinical regulatory compliance for investigational and marketed products and manage the preparation, review, and finalization of submission packages and responses to Health Authorities. This position will contribute to the preparation of INDs, CTAs, BLAs, MAAs, and any other application for health authorities in line with local requirements.

Essential Functions

• Lead Health Authorities direct reports 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.
• Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, data management plan, and any other clinical trial associated document
• Provide input to the design and reporting of clinical studies sponsored by IBRX
• Manage the preparation of the relevant clinical sections of written summaries for regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and any other applications.
• Create and maintain project plans for health authorities operations
• Participate in cross-functional teams and provide support to others in the preparation, analysis, and documentation of studies
• Lead external stakeholder engagement throughout the submission lifecycle, coordinating with CROs, external regulatory consultants, and subject matter experts / key opinion leaders to gather data, craft high‑quality RFI responses, and foster constructive agency relationships
• Prepare and assign responses to Health Authority comments and questions pertaining to clinical issues. Maintain timelines on responses and assemble the final, completed submission package.
• Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications
• Ensure continuous monitoring of, and incorporation of, the most recent regional and local health‑authority guidances; interpret amendments and apply updated requirements to all regulatory dossiers to mitigate agency queries and preserve submission integrity
• Oversee version‑control governance by supervising a centralized document repository, defining naming‑convention standards, authorizing change‑tracking procedures, and approving final module versions prior to electronic upload to ensure audit‑ready documentation 
• Develop and maintain product‑development road maps based on projected approval dates
• 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 10+ years of relevant progressive experience required; or
• Master’s Degree in life sciences or technical discipline with 8+ years of relevant progressive experience required; or
• Doctorate degree in life sciences or technical discipline with 6+ years of relevant progressive experience required.
• Experience managing staff required
• Experience in the management and preparation of the submission of clinical modules in eCTD format required.
• Experience in medical writing
• Experience with organizing responses to Health Authority information requests required.
• Experience with regulatory submissions outside of the US preferred

Knowledge, Skills, & Abilities

• Expert knowledge of Health Authority guidance documents and requirements
• Strong leadership skills with the ability to direct and develop professional staff
• Expert knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines
• Expert knowledge of clinical documentation
• 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
• Ability to successfully manage multiple changing deadlines and operate in ambiguity

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.

$185,000 (entry-level qualifications) to $203,500 (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.