Clinical Trial Agreement – Contract Attorney

Job Description

RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving cancer patient survival by efficiently developing targeted innovative drugs that harness the power of radioisotopes. RayzeBio is led by a successful and experienced entrepreneurial team and backed by top tier healthcare investors.

Primary Responsibilities:

  • Provide legal support and regulatory guidance to internal business partners to facilitate the early development clinical trial-related contracting, sponsor or investigator-initiated study agreements, collaborative research, and other vendor agreements supporting the clinical team.
  • Draft, negotiate and review Clinical Trial Agreements, Master Services Agreements, Statements of Work, CRO and other clinical research related vendor agreements.
  • Provide general legal support related to clinical research regulatory compliance, including the review clinical research-related documents and agreements, study protocols, informed consent requirements and IRB requirements.

Additional Responsibilities:

  • Developing a deep understanding of the business and operational goals while developing and maintaining positive relationships with colleagues at all levels of the organization.
  • Collaborating with colleagues to provide advice on legal issues and driving projects to completion.
  • Assisting with contractual arrangements, legal and regulatory compliance, and general corporate legal issues.

Required Qualifications

  • Minimum of 4 years legal attorney experience in a law firm and/or in-house setting that includes:
    • Clinical trial/research contract drafting and negotiation.
    • Knowledge of laws, regulations and industry standards governing clinical research.
  • Admitted to practice law in at least one state and in good standing of applicable bar association(s).

Preferred Qualifications

  • Working knowledge of healthcare laws and regulations including:
  • HIPAA
  • GDPR
  • Medicare/Medicaid
  • False Claims Act
  • Federal Anti-Kickback Statute

Education

Bachelor’s Degree plus Juris Doctor (JD) are required.

Compensation

Competitive base salary with bonus, PTO, stock options, and full benefits; casual work environment

To apply please send resume to ahaddach@rayzebio.com.