Senior Clinical Research Counsel
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Job Description
Senior Clinical Research Counsel managing a wide range of contracts for clinical trials at ImmunityBio. Drafting, reviewing, and negotiating clinical trial agreements and ensuring compliance with regulations.
Responsibilities:
- 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.
Requirements:
- 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.
- 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 clinical development process.
- Proven ability to handle a wide range of general corporate and commercial contracts beyond the clinical context.
- In-depth knowledge of federal, state, and, preferably, international laws and regulations governing clinical research (e.g., FDA, GCP, ICH guidelines, data privacy regulations).
- Ability to interpret and apply such laws, regulations and policies to inform business activities
- Integrity and ethics, adaptability, innovation/creativity
- Analytical thinking, negotiation skills, and decision-making skills
Benefits:
- Medical, Dental and Vision Plan Options
- Health and Financial Wellness Programs
- Employer Assistance Program (EAP)
- Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
- Healthcare and Dependent Care Flexible Spending Accounts
- 401(k) Retirement Plan with Company Match
- 529 Education Savings Program
- Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
- Paid Time Off (PTO) includes: 11 Holidays
- Exempt Employees are eligible for Unlimited PTO
- Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
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