Principal Specialist, Health Authorities
ImmunityBio, Inc.
Summary
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.
Job description
Position Summary
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.
Essential Functions
- 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
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
- 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
Knowledge, Skills, & Abilities
- 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
Requirements
- Bachelor's Degree in life sciences or technical discipline with 10+ years of relevant progressive experience; or Master's degree in life sciences or technical discipline with 8+ years of relevant progressive experience
- Experience in the preparation of the submission of clinical modules in eCTD format
- Familiarity with organizing responses to Health Authority information requests
- 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
- Strong organizational skills, written and oral communication skills, and attention to detail
- Ability to successfully manage multiple changing deadlines and operate in ambiguity
Benefits
- Medical, Dental & Vision
- Health and Financial Wellness Programs
- Employee Assistance Program
- Life and AD&D Insurance
- Short-Term Disability Insurance
- Long-Term Disability Insurance
- Flexible Spending Accounts
- 401(k) Matching
- 529 Education Savings Program
- Legal Services
- Identity Theft Protection
- Pet Insurance
- Employee Discounts and Rewards
- Paid Time Off
- 11 Holidays
- Unlimited PTO
- Discretionary Bonus
- Equity Award
Company overview
ImmunityBio, Inc. is a clinical-stage biotechnology company headquartered in San Diego, California, that specializes in developing innovative cell and immunotherapy products for the treatment of advanced cancers and infectious diseases. Founded in 2014 by Dr. Patrick Soon-Shiong, the inventor of the world's first protein nanoparticle drug Abraxane, the company focuses on creating therapies that strengthen patients' natural immune systems to combat diseases. ImmunityBio's pipeline includes promising candidates like ANKTIVA for various cancer indications, with a particular emphasis on bladder cancer, lung cancer, and other solid tumors. The company employs approximately 500-1,000 professionals and operates internationally with facilities across the United States. ImmunityBio's approach centers on activating both branches of the immune system to attack diseased cells while building immunological memory for long-term protection. The company is publicly traded on NASDAQ under the ticker symbol IBRX and continues to advance its clinical programs through strategic collaborations and ongoing research initiatives.