Clinical Trial and R&D Contracting Lawyers

Overview

This role involves providing legal expertise in clinical trial and research and development (R&D) contracting within the life sciences industry. The position supports organizations engaged in pharmaceutical, biotechnology, medical device, or contract research operations.

Responsibilities

• Lead drafting, negotiation, and management of global clinical trial agreements and related documents with sophisticated counterparties such as hospitals, academic medical centers, universities, government agencies, and large healthcare systems.
• Serve as primary legal support for contract research organization (CRO)-facing arrangements, including master services agreements, work orders, change orders, and related vendor contracts, ensuring clear allocation of responsibilities, data rights, intellectual property, and risk.
• Support R&D and pre-clinical activities, including:
  • Sponsored research agreements with academic and research institutions
  • Material transfer agreements (inbound and outbound)
  • Non-clinical/GLP study agreements and related R&D collaborations
• Draft, review, and negotiate a broad range of clinical and R&D agreements, including:
  • Clinical Trial Agreements (industry-sponsored and investigator-initiated)
  • Informed consent forms and related patient-facing documentation
  • Collaboration, consulting, confidentiality (CDAs/NDAs), and data use agreements
  • Supply, manufacturing, and ancillary services agreements supporting clinical development
• Provide practical, business-oriented legal advice to clinical operations, R&D, medical, regulatory, data/biostatistics, and procurement teams in a fast-paced environment.
• Advise on global regulatory and compliance requirements affecting clinical research, including FDA regulations, ICH GCP, GDPR and other data privacy rules, transparency/disclosure requirements, and anti-bribery/anti-corruption considerations.
• Collaborate with cross-functional stakeholders to develop playbooks, templates, and process improvements that accelerate study start-up while appropriately managing risk.

Minimum Qualifications

• At least 5 years of post-qualification legal experience at a pharmaceutical, biotechnology, medical device, or CRO organization, or in a law firm serving such clients.
• Demonstrated experience leading global clinical contracting, including multi-country or multi-site clinical trial agreements and related documentation.
• Substantial, hands-on experience drafting and negotiating CRO agreements such as master services agreements, work orders, and related vendor contracts.
• Meaningful experience supporting R&D and pre-clinical work, including sponsored research agreements, material transfer agreements, and other early-stage R&D or non-clinical study agreements.
• Strong knowledge of laws, regulations, and industry standards governing clinical research, including FDA regulations, ICH Guidelines, Good Clinical Practices (GCPs), and applicable data privacy and human subject protection requirements.
• Proven ability to provide clear, risk-balanced guidance directly to business clients and collaborate effectively with cross-functional teams in remote or hybrid environments.
• Licensed and in good standing to practice law in the state of primary residence.

Compensation & Benefits

• Estimated total compensation for full-time attorney roles ranges from $104,500 to $325,000 per year.
• For non-attorney roles, estimated total compensation ranges from $71,250 to $309,750 per year.
• Compensation decisions are based on factors including experience, skills, certifications, location, and business needs.
• Additional benefits may include health, dental, and vision insurance; paid holidays and paid time off; flexible work arrangements; and professional development opportunities and tools.

Location

This role supports remote or hybrid work environments, collaborating with cross-functional teams across various locations.