Company Overview
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 we believe 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.
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 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 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 documentationAbility 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 as noted in the offer letter. 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…