Agency Temporary, Contracts Counsel

Overview

A life sciences-focused organization is seeking a Contracts Counsel to draft, review, and negotiate a variety of contracts, primarily 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

• Draft, review, and negotiate complex CTAs, master service agreements (MSAs), confidentiality agreements, material transfer agreements, and vendor service agreements with research sites and third-party vendors.
• Handle non-clinical vendor agreements including consulting agreements, MSAs for general business support (e.g., IT, marketing, facilities), and supply agreements.
• Ensure compliance of clinical trial contracts and processes with federal, state, and international laws and regulations, including FDA regulations, Good Clinical Practice (GCP) guidelines, and data privacy laws such as HIPAA and GDPR.
• Collaborate with internal teams to develop, update, and maintain standard agreement templates and negotiation playbooks to enhance efficiency and consistency.
• Identify legal risks in contracts and communicate these to internal stakeholders with mitigation strategies.
• Assist with legal aspects of patient informed consent forms (ICFs) to ensure participant protection and regulatory compliance.
• Stay updated on legislative and regulatory changes affecting clinical research and incorporate these into company templates and processes.
• Design and deliver internal training on R&D legal best practices; maintain templates and lead process improvement initiatives.
• Create, edit, and adhere to Standard Operating Procedures (SOPs) and standardize templates.
• Participate in ad-hoc and cross-functional projects to support business needs and professional development.

Requirements

• Juris Doctor (JD) degree from an accredited law school.
• Active membership in a State Bar Association, preferably California.
• Minimum of 5 years of experience at a large law firm and/or legal department within a Life Sciences or Pharmaceutical company.
• Strong knowledge of statutes, regulations, and industry standards governing GxP, clinical research, trial transparency, and product commercialization.
• Expertise in drafting and negotiating clinical trial-related agreements and understanding of the clinical development process.
• Ability to manage a broad range of general corporate and commercial contracts.
• In-depth knowledge of federal, state, and international laws and regulations related to clinical research (e.g., FDA, GCP, ICH guidelines, data privacy regulations).
• Excellent oral and written communication skills.
• Strong organizational skills and discretion in handling confidential information.
• Analytical thinking, negotiation, decision-making skills, integrity, adaptability, and creativity.

Working Environment

• This is a remote position.
• Regular work schedule is Monday through Friday during standard business hours, with flexibility available upon manager approval.

Compensation & Benefits

• Eligible for discretionary bonus and equity awards.
• Hourly base pay ranges based on qualifications and geographic location:
  • National Market (all markets except Premium): $77.50 (entry-level) to $85.25 (highly experienced) per hour.
  • Premium Market (Los Angeles, San Diego, San Francisco, New York City, Chicago, Boston): $88.50 (entry-level) to $97.35 (highly experienced) per hour.

Additional Information

• The organization is a mandatory COVID-19 vaccination employer; employees must be fully vaccinated by their start date unless a medical or religious accommodation is granted.
• Proof of vaccination is required prior to starting.
• The employer may require vaccine boosters in compliance with applicable laws.
• The application window is open for 60 days from posting or until the position is filled or closed.
• Compensation will be determined based on the applicant's skills, qualifications, experience, and position requirements.