Agency Temporary, Contracts Counsel

Position Summary

The Contracts 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

• 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.
• 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.
• 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).
• Collaborate with internal stakeholders to develop, update, and maintain standard agreement templates and negotiation "playbooks" to improve efficiency and consistency.
• Identify potential legal risks within contractual agreements and communicate these risks to internal decision-makers, offering mitigation strategies.
• Assist with the legal aspects of patient informed consent forms (ICFs) to ensure participant protection and compliance.
• Stay current with changes in legislation and regulatory environments affecting clinical research and integrate updates into company templates and processes.
• Design and deliver internal training on R&D legal best practices; maintain templates/playbooks and lead process‑improvement initiatives.
• Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
• Perform ad-hoc and cross-functional projects assigned to support business needs and provide developmental opportunities.

Education & Experience

• Juris Doctor degree from an accredited law school is required.
• Active member of a State Bar Association (preferably California) required.
• 5+ years of experience at a large law firm and/or the legal department of a Life Sciences or Pharmaceutical company required.

Knowledge, Skills, & Abilities

• Understanding of statutes, regulations, and industry standards governing GxP, clinical research, trial transparency, and product commercialization
• 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

Working Environment / Physical Environment

• This position works remotely.
• Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.