Associate General Counsel Senior, Clinical Research- Remote

Overview

This role provides legal advice and counsel to a national center for clinical trials, an institutional review board (IRB), the office of clinical research, the office of sponsored programs, and the clinical research function generally. The position involves ensuring compliance with regulations from the Department of Health and Human Services and the Food and Drug Administration, including oversight related to the Office of Research Integrity and the Human Research Protection Program.

Responsibilities

• Provide legal counsel and guidance on clinical research and IRB activities.
• Manage negotiation processes for clinical trial agreements and other related agreements such as data use and collaboration agreements.
• Draft, review, and negotiate modifications to agreements to ensure compliance with organizational requirements and standards.
• Develop and maintain contract templates and playbooks to facilitate contract negotiations.
• Collaborate with industry sponsors, academic institutions, and other healthcare systems to facilitate agreements for collaborative research.
• Review grants and grant applications for legal issues and risks, working with internal stakeholders to clarify organizational obligations.
• Provide advice and counsel on investigatory matters related to clinical research and the IRB.

Requirements

• Juris Doctor (JD) degree.
• Licensed attorney authorized to practice law in any U.S. state.
• Minimum of 7 years of experience representing healthcare entities, working in contract research organizations, pharmaceutical companies, or a combination thereof.
• Demonstrated ability to act as counsel on a variety of healthcare legal matters, with a focus on clinical research and IRB issues.
• Experience performing legal research, drafting, and editing clinical research legal documents.
• Proficiency in drafting and reviewing clinical trial agreements, confidentiality agreements, data use agreements, and collaboration agreements.
• Strong organizational and project management skills to manage multiple legal transactions and issues effectively and timely.
• Specialized knowledge of local, state, and federal laws and regulations related to clinical research.
• Ability to integrate digital tools and artificial intelligence in legal research, reasoning, drafting, and communications.
• Experience handling confidential and sensitive matters involving healthcare providers, pharmaceutical companies, management, and regulatory agencies.
• Skills in analyzing laws, regulations, case law, standards, governing documents, contracts, and risk management issues to protect the organization from legal risk.
• Excellent verbal and written communication skills.
• Ability to communicate and collaborate effectively with employees at all levels, management, executives, and external organizations.
• Ability to address difficult and controversial issues, organizational policies, procedures, and federal and state regulations.
• Ability to work effectively within a complex corporate system environment.

Compensation & Benefits

• This is a remote position.

Additional Information

All responsibilities and requirements are subject to reasonable accommodation for individuals with disabilities. This job description does not encompass all duties that may be assigned; employees are expected to perform other job-related tasks as requested by leadership.