Senior Clinical Research Counsel

Overview

A commercial-stage biotechnology organization is seeking a Senior Clinical Research Counsel to manage and negotiate a broad range of contracts, primarily focusing on Clinical Trial Agreements (CTAs). This role requires a strong understanding of clinical trial laws and regulations, providing legal advice that balances business goals with risk management.

Responsibilities

• Negotiate clinical trial agreements across multi-site, multi-country trials, managing a high-volume contract portfolio with risk-based prioritization and playbooks to ensure efficient turnaround.
• Advise Clinical Operations and Regulatory teams on contracting risks, indemnification, intellectual property, data use, and budget/payment terms.
• Identify and communicate potential legal risks in contracts, offering mitigation strategies.
• Ensure compliance of clinical trial contracts and processes with federal, state, and international laws and regulations, including FDA regulations, Good Clinical Practice (GCP), HIPAA, and GDPR.
• Assist with legal aspects of patient informed consent forms to ensure participant protection and compliance.
• Develop templates and negotiate agreements related to data protection and privacy, including GDPR and Standard Contractual Clauses (SCCs).
• Develop policies and procedures addressing anti-kickback considerations in investigator and institutional payments.
• Stay updated on legislative and regulatory changes affecting clinical research and integrate updates into 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 various non-clinical vendor agreements, including consulting, IT, marketing, facilities, and supply agreements.
• Support due diligence, licensing, and collaboration agreements involving clinical-stage assets.
• Develop and maintain template agreements, negotiation playbooks, fallback positions, and contracting guidance to scale the legal function.
• Identify process improvements and contribute to contract lifecycle management system optimization.
• Perform ad-hoc and cross-functional projects to support business needs and professional development.

Requirements

• Juris Doctor (JD) degree.
• Membership in a State Bar Association, preferably California.
• Minimum of 10 years of experience at a large law firm and/or legal department of a Life Sciences or Pharmaceutical company.
• Excellent oral and written communication skills.
• Strong organizational skills and ability to maintain confidentiality.
• Expertise in drafting and negotiating clinical trial-related agreements and understanding of the clinical development process.
• Proven ability to handle a wide range of general corporate and commercial contracts.
• In-depth knowledge of federal, state, and international laws and regulations governing clinical research (FDA, GCP, ICH guidelines, data privacy regulations).
• Ability to interpret and apply laws, regulations, and policies to inform business activities.
• Integrity, ethics, adaptability, creativity, analytical thinking, negotiation, and decision-making skills.

Working Environment

• Position may be remote or on-site depending on candidate location.
• Regular Monday to Friday schedule within standard business hours; flexible scheduling available with manager approval.
• Travel up to 15% as needed.
• Must be able to work in a standard office setting and use standard office equipment.
• Ability to lift and carry materials up to 30 pounds.

Compensation & Benefits

• Eligible for discretionary bonus and equity awards.
• Annual base salary range:
  • National Market: $200,000 (entry-level) to $220,000 (highly experienced).
  • Premium Markets (Los Angeles, San Diego, San Francisco, New York City, Chicago, Boston): $217,000 to $238,700.
• Comprehensive benefits package including medical, dental, and vision plans.
• Health and financial wellness programs.
• Employee assistance program.
• Company-paid and voluntary life/AD&D, short-term and long-term disability insurance.
• Flexible spending accounts for healthcare and dependent care.
• 401(k) retirement plan with company match.
• 529 education savings program.
• Voluntary legal services, identity theft protection, pet insurance, employee discounts, rewards, and perks.
• Paid time off includes 11 holidays; exempt employees eligible for unlimited PTO; non-exempt employees eligible for 10 vacation days, 56 hours of health pay, 2 personal days, and 1 cultural day.

Location

• Position location flexible; remote or on-site depending on candidate geography.

Equal Opportunity

The employer is an equal opportunity organization committed to diversity and provides equal employment opportunities without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity or expression, or other protected status by law.