From ImmunityBio's posting. “We” and “our” refer to the employer.
Company Overview
ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease.
Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy.
These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.
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 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.
About this listing
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