Principal Specialist, Health Authorities

About the company

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 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.

ImmunityBio offers the opportunity to join a publicly traded biopharmaceutical company headquartered in Southern California, work with a collaborative team across different areas of the company, and join a growing organization with professional development opportunities.

About the role

The Principal Specialist, Health Authorities will assist in the development of global clinical regulatory strategy for investigational and marketed products and assist with the preparation, review, and finalization of submission packages and responses to Health Authorities. The Principal Specialist, Regulatory Clinical Science will provide a high-level of expertise to the organization in ensuring the regulatory submissions conform to local Health Authority requirements.

Responsibilities

• Evaluate 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
• Assemble the reporting of clinical studies sponsored by IBRX
• Draft and finalize documents for regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, briefing books, and any other application documents
• Prepare responses to Health Authority comments and questions pertaining to clinical issues
• Assist with version‑control governance by supervising a centralized document repository, applying naming‑convention standards, authorizing change‑tracking procedures, and assisting with final module versions prior to electronic upload to ensure audit‑ready documentation
• Provide guidance, training, and expert opinion to others in the preparation, analysis, and documentation of studies
• Monitor and analyze emerging Health‑Authority guidance to anticipate regulatory shifts and advise cross‑functional teams
• Perform ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities

Requirements

• 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
• Experience in the preparation of the submission of clinical modules in eCTD format required
• Familiarity with organizing responses to Health Authority information requests required
• Familiarity with regulatory submissions outside of the US a bonus

Skills

• Strong knowledge of Health Authority clinical guidance documents and requirements
• Expert knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines
• Strong 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

Work 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.

Pay

The annual base pay range for this position is $164,000 (entry-level qualifications) to $180,000 (highly experienced) annually. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location. This position is eligible for a discretionary bonus and equity award.

Benefits

• 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