ImmunityBio
Associate Director, Health Authorities
Summit, NJ · Director
Sponsorship not specifiedDetected 30 days ago
StatisticsComplianceClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationMentoringOrganizational SkillsRegulatory Affairs
About the role
- Prepare and assign responses to Health Authority comments and questions pertaining to clinical issues.
Responsibilities
- 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.
- 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.
- Manage the day-to-day activities of staff to include the hiring and training of new team members, coaching employees and monitoring performance.
- Provide input to the design and reporting of clinical studies sponsored by IBRX
- Manage the preparation of the relevant clinical sections of written summaries for regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and any other applications.
- Participate in cross-functional teams and provide support to others in the preparation, analysis, and documentation of studies
- Develop and maintain product‑development road maps based on projected approval dates
- Performs ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities.
- Review 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
- Maintain timelines on responses and assemble the final, completed submission package.
Requirements
- Bachelor's Degree in life sciences or technical discipline with 10+ years of relevant progressive experience required
- Master's Degree in life sciences or technical discipline with 8+ years of relevant progressive experience required
- Doctorate degree in life sciences or technical discipline with 6+ years of relevant progressive experience required.
- Experience managing staff required
- Experience in the management and preparation of the submission of clinical modules in eCTD format required.
- Expert knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines
Nice to have
- Experience with regulatory submissions outside of the US preferred
Skills
- Knowledge, Skills, & Abilities
Compensation
- The annual base pay range for this position is below.
Benefits
- Lead Health Authorities direct reports by delegating projects, establishing and meeting timelines, and ensuring high quality work products
- Create and maintain project plans for health authorities operations
Visa & Work Authorization
- race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law
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