Principal Regulatory Toxicology Specialist

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 Principal Regulatory Toxicologist will be responsible for participating in the strategy for nonclinical testing for investigational and marketed products and managing preparation of dossiers. The Principal Regulatory Toxicologist will interact with cross-functional teams. Key responsibilities will include contributing to the development of submission strategies for nonclinical sections of regulatory documents for ImmunityBio, Inc. They will provide a high level of expertise to the organization regarding evaluation and reporting of drug safety related to the nonclinical toxicology of company products.

Essential Functions

• Interpret nonclinical data in line with the study protocol design and execution, ensuring adherence to regulatory requirements and responding to relevant regulatory requests.
• Contribute to the preparation of regulatory submissions including INDs, NDAs, and BLAs which includes preparation of written and tabular nonclinical summaries.
• Contribute to the preparation or review of documents including study reports, investigator brochures, pharmacy manuals, protocols, drug labeling and safety data sheets.
• Provide expert opinion on toxicology studies planned or performed.
• Contribute to the design, monitoring, and reporting of toxicology studies.
• Interact with other functional areas, such as environmental health and safety, when needed to address toxicology related matters.
• Create, edit , and adhere to standard operation procedures as needed.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs.

Education & Experience

• Master’s Degree in life sciences or equivalent with 8+ years of toxicology regulatory experience in the biotech or pharmaceutical industry required; or
• Doctorate Degree in life sciences or equivalent with 6+ years of toxicology regulatory experience in the biotech or pharmaceutical industry required.
• Experience in interpreting nonclinical data and writing nonclinical sections of reports and regulatory submissions required.
• Expert knowledge of Health Authority nonclinical guidance documents and requirements required.
• Experience with organizing responses to Health Authority requests required.
• Experience as a Study Director/Study Monitor with ability to design and execute toxicology studies to determine the nonclinical safety of therapeutics preferred.
• Experience with regulatory submissions outside of the US strongly preferred.

Knowledge, Skills, & Abilities

• Strong knowledge in therapeutic areas of oncology and metabolic diseases.
• Familiar with the use and application of computational toxicology tools to utilize in-silico modeling for compliance efforts.
• Strong knowledge of toxicokinetics as well as bioanalytical method development and validation.
• 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.
• A Principal Regulatory Toxicologist may need to sit for long periods of time and use various computer programs.
• This desk-based role