Senior Specialist, Health Authorities
ImmunityBio, Inc.
Summary
The Senior Specialist, Health Authorities will assist in the development of global clinical regulatory strategy for investigational and marketed products and assist with the preparation of dossiers in eCTD format. The Senior Specialist, Health Authorities will provide a high-level of expertise to the organization in ensuring the conduct of clinical trials conform to Health Authority requirements.
Job description
Position Summary
The Senior Specialist, Health Authorities will assist in the development of global clinical regulatory strategy for investigational and marketed products and assist with the preparation of dossiers in eCTD format. The Senior Specialist, Health Authorities will provide a high-level of expertise to the organization in ensuring the conduct of clinical trials conform to Health Authority requirements.
Essential Functions
- Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan
- Assemble the reporting of clinical studies performed sponsored by IBRX
- Draft written summaries for regulatory submissions including INDs, NDAs, and BLAs
- Prepare or review documents including investigator brochures, pharmacy manuals, protocols, clinical study reports, annual reports, DSURs, and clinicaltrials.gov entries, etc.
- Provide support and training to others in the preparation, analysis, and documentation of studies
Education & Experience
- Bachelor’s Degree in life sciences or technical discipline with 7+ years of relevant progressive experience required; or Master’s degree in life sciences or technical discipline with 5+ years of relevant progressive experience required
- Experience in the preparation of the submission of clinical modules in eCTD format
- Familiarity with organizing responses to Health Authority information requests
- Familiarity with regulatory submissions outside of the US a bonus
Knowledge, Skills, & Abilities
- 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
Requirements
- Bachelor’s Degree in life sciences or technical discipline with 7+ years of relevant progressive experience required; or Master’s degree in life sciences or technical discipline with 5+ years of relevant progressive experience required
- Experience in the preparation of the submission of clinical modules in eCTD format
- Familiarity with organizing responses to Health Authority information requests
- Familiarity with regulatory submissions outside of the US a bonus
- 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
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- 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) Retirement Plan with Company Match
- 529 Education Savings Program
- Legal Services
- Identity Theft Protection
- Pet Insurance
- Employee Discounts, Rewards, and Perks
- Paid Time Off
- Paid Holidays
- 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.