Principal Regulatory Toxicology Specialist

ImmunityBio, Inc.•Summit, NJ

5d•$230,000 - $253,000•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

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.

Responsibilities

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.

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