Senior Legal Counsel, Clinical
Core
Senior Legal Counsel driving the drafting, negotiation, and execution of high-volume clinical research agreements to advance drug candidates into clinical development.
Role type
Senior in-house legal counsel (clinical)
Builds
Clinical trial agreements, master service agreements, investigator agreements, site contracts, and patient/subject-related agreements
Domain
Biotechnology / Clinical Development / Life Sciences Law
Required skills
Clinical trial agreement structuring, MSA negotiation, GCP/ICH regulatory guidelines, CRO outsourcing models, global multi-jurisdictional contracting (US/UK/EU), clinical data rights and IP provisions, outside counsel management
Preferred skills
AI technology integration in legal operations, computational biology legal experience
Technologies
None stated
Responsibilities
Draft, review, negotiate, and execute clinical research agreements; Partner with Clinical Development team to streamline study start-up; Identify and mitigate legal, regulatory, IP, and compliance risks; Collaborate with cross-functional Legal and Business Operations colleagues; Manage outside counsel and clinical transaction legal budget
Seniority
Senior, hands-on IC
