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 global clinical trial agreements, CRO-facing arrangements, and R&D collaborations with a focus on compliance, risk management, and business-oriented legal advice.

Responsibilities

• Lead drafting, negotiation, and management of global clinical trial agreements and related documents with hospitals, academic medical centers, universities, government agencies, and large healthcare systems.
• Serve as primary legal support for CRO-facing arrangements, including master services agreements, work orders, change orders, and vendor contracts, ensuring clear allocation of responsibilities, data rights, intellectual property, and risk.
• Support R&D and pre-clinical activities such as sponsored research agreements, material transfer agreements (inbound and outbound), non-clinical/GLP study agreements, and related 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 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 managing risk appropriately.

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, 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 globally.