Senior Clinical Research Counsel

Company Overview
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. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. 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. The goal: to reprogram the patient’s immune system and treat the host rather than just the disease.

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 Clinical Research Counsel will be responsible for drafting, reviewing, and negotiating a wide range of contracts, with a primary focus on Clinical Trial Agreements (“CTAs”).  The role will apply a robust understanding of the laws and regulations governing clinical trials while providing pragmatic legal advice that balances business objectives with risk mitigation.

Essential Functions

• Primary responsibility will be the negotiation of clinical trial agreements (CTAs) across multi-site, multi-country trials.  Manage a high-volume contract portfolio, applying risk-based prioritization and playbooks to ensure efficient turnaround without compromising legal protection.
• Advise Clinical Operations and Regulatory teams on contracting risk, indemnification, intellectual property allocation, data use, and budget/payment terms.  Identify potential legal risks within contractual agreements and communicate these risks to internal decision-makers, offering mitigation strategies.
• Ensure all clinical trial contracts and processes comply with applicable federal, state, and international laws and regulations, including FDA regulations, Good Clinical Practice (GCP) guidelines, and data privacy laws (e.g., HIPAA, GDPR).
• Assist with the legal aspects of patient informed consent forms (ICFs) to ensure participant protection and compliance.
• Develop templates and negotiate agreements relating to data protection and privacy issues, including GDPR, SCCs, and related data protection matters.
• Develop policies and procedures surrounding anti-kickback considerations in investigator and institutional payments in the clinical trial context.
• Stay current with changes in legislation and regulatory environments affecting clinical research and integrate updates into company templates and processes.
• Structure, negotiate, and manage master service agreements and work orders with CROs, central labs, imaging vendors, and other clinical research service providers.
• Review, draft, and negotiate a variety of non-clinical vendor agreements, including consulting agreements, master services agreements for general business support (e.g., IT, marketing, facilities), and supply agreements as needed.
• Support due diligence, licensing, and collaboration agreements involving clinical-stage assets as needed.
• Develop and maintain template agreements, negotiation playbooks, fallback positions, and contracting guidance to scale the function efficiently.
• Identify process improvements and contribute to contract lifecycle management (CLM) system optimization.
• Perform ad-hoc and cross-functional projects assigned to support business needs and provide developmental opportunities.

Education & Experience

• Juris Doctor degree required
• Member of a State Bar Association (preferably California) required
• 10+ years of experience at a large law firm and/or the legal department of a Life Sciences or Pharmaceutical company required.

Knowledge, Skills, & Abilities

• Excellent oral and written communication skills
• Excellent organizational skills
• Demonstrates discretion and ability to maintain confidentiality of information
• Demonstrated expertise in drafting and negotiating clinical trial-related agreements and a strong understanding of the