Clinical Trial and R&D Contracting Lawyers

We are currently seeking Clinical Trial and R&D Contracting Lawyers to work with leading organizations in the Life Sciences industry.

Responsibilities

• Lead the drafting, negotiation, and management of global clinical trial agreements and related documents with sophisticated counterparties, including 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 related vendor contracts, ensuring clear allocation of responsibilities, data rights, IP, 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/biostats, and procurement teams in a fast‑paced environment.
• Advise on global regulatory and compliance requirements affecting clinical research (e.g., FDA regulations, ICH GCP, GDPR and other data privacy rules, transparency/disclosure requirements, anti‑bribery/anti‑corruption considerations).
• Partner closely with cross‑functional stakeholders to develop playbooks, templates, and process improvements that accelerate study start‑up while appropriately managing risk.

Minimum Qualifications

• 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 (not limited to a single region), including multi‑country or multi‑site clinical trial agreements and related documentation.
• Substantial, hands‑on experience drafting and negotiating CRO agreements (e.g., master services agreements, work orders, and related vendor contracts) as a core part of your practice.
• Meaningful experience supporting R&D and pre‑clinical work, including:
  • Sponsored research agreements with academic or research institutions
  • Material transfer agreements
  • Other early‑stage R&D or non‑clinical study agreements
• Strong knowledge of laws, regulations, and industry standards governing clinical research, such as 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 to collaborate effectively with cross‑functional teams in a remote or hybrid environment.
• Licensed and in good standing to practice law in your state of primary residence.

Compensation, Benefits & Location:

This role offers competitive compensation in a range starting at $135,000 and increased based on experience, location etc, as well as a highly competitive benefits package in the alternative legal services marketplace that includes health benefits, 401K and more. Axiomites also get access to professional development resources and learning and development programs. Axiomites predominately work remotely, with the exception that some clients require on-site presence.

Axiom is the global leader in high-caliber, on-demand legal talent. Covering North America, the UK, Europe, and APAC, we enable legal departments to drive efficiency and growth and meet the demands of today’s business landscape with best in breed alterative legal services.

Axiom is a leader in diversity, inclusion, and social engagement. Diversity is core to our values and we are proud to be an equal opportunity employer. We are proud to be named a best place to work for LGBTQ+ Equality, earning top marks in the 2021 Corporate Equality Index for the second consecutive year. Axiom’s legal department is Mansfield certified and is committed to considering at least 50% diverse candidates for leadership roles and outside counsel representation.

Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Learn more about working at Axiom.

Equal Opportunity Employer: Axiom ensures equal employment opportunity in recruitment and employment, without discrimination or harassment on the basis of race, color, nationality, national or ethnic origin, religious creed or belief, political opinion, sex, gender reassignment, pregnancy or maternity, age, disability, alienage or citizenship status, marital (or civil or other partnership recognized by law) status, genetic predisposition or carrier status, sexual orientation, military service, or any other characteristic protected by applicable law. Axiom prohibits and will not tolerate any such discrimination or harassment.

Accommodation for Individuals with Disabilities: Upon request and consistent with applicable laws, Axiom will provide reasonable accommodations for individuals with disabilities who require an accommodation to participate in each stage of the recruitment process. To request an accommodation to complete the application form, please contact us at [email protected] and include “Applicant Accommodation” in the subject line.

Axiom respects your privacy. For an explanation of the kind of information we collect about you and how it is used, our full privacy notice is available at https://www.axiomlaw.com/privacy-notice.

Employment with Axiom may be contingent upon successful completion of a background check, providing proof of identity, and possessing the necessary legal authorization to work.

By submitting an application, you acknowledge that all information contained therein, and provided at any part of the application process, is correct and accurate to the best of your knowledge.

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