Description:
An American Biotechnology Company Legal Operations Team is seeking an experienced attorney to partner with, and provide strategic legal advice to, the Global Research and Development teams that support An American Biotechnology Company's robust and growing pipeline. The attorney should have experience in regulatory law and R&D and will provide advice on a wide range of legal, regulatory, contractual, privacy, and compliance issues related to drug discovery and development. The attorney will be an integral part of a proactive and solutions-oriented legal team that provides advice to advance An American Biotechnology Company's pipeline.As a Legal Counsel- R&D Operations attorney, a typical day may include:
- Providing advice and counsel to global development programs in a designated therapeutic area
- Advising leaders in the Global Research and Development team and others on regulations and laws impacting the R&D teams
- Collaboratively interacting with internal business stakeholders, third party partners including CROs, and R&D management
- Drafting and negotiating a wide range of R&D agreements including clinical trial agreements and other contracts in support of our global clinical trial operations
- Counseling on patient privacy and patient rights on matters related to clinical research Serving as a subject matter expert on R&D matters within the Law Department and collaborate with other legal functions (e.g., Business Development and Contracting, Compliance, Data Protection/Privacy, Litigation and Products/Regulatory Law group)
- Conducting training to client groups on a variety of R&D legal and regulatory issues
