Our Client is a pioneering public, commercial stage biopharmaceutical company committed to driving progress through cutting-edge research and development. They are seeking a highly skilled and experienced Senior Counsel, focused on Clinical Contracts and Research and Development, to join its growing legal team. The ideal candidate will possess deep expertise in clinical trials, research agreements, and complex legal issues pertaining to drug development. As Senior Counsel, you will provide strategic legal guidance to support our clinical and R&D operations, ensuring compliance with regulations and alignment with corporate objectives.
Key Responsibilities:
- Clinical Contracts Management:
- Draft, review, and negotiate clinical trial agreements (CTAs), investigator agreements, and related documents.
- Advise on clinical trial protocol compliance, regulatory requirements, and risk management.
- Develop and implement strategies for efficient and effective management of clinical contract negotiations and execution.
- Research and Development Legal Support:
- Provide legal counsel on R&D activities, including collaborations, licensing agreements, and intellectual property matters.
- Support the development and negotiation of strategic partnerships, joint ventures, and other collaborative agreements.
- Ensure adherence to Good Clinical Practice (GCP), FDA regulations, and other relevant guidelines.
- Regulatory Compliance and Risk Management:
- Monitor and interpret changes in regulations and industry standards affecting clinical trials and R&D activities.
- Implement compliance programs and provide training to internal stakeholders on legal and regulatory matters.
- Address and manage legal risks associated with clinical development and research projects.
- Cross-Functional Collaboration:
- Partner with internal teams, including Clinical Operations, R&D, Regulatory Affairs, and Finance, to align legal strategies with business objectives.
- Provide legal advice on strategic initiatives and operational issues impacting clinical and research programs.
Qualifications:
- Juris Doctor (JD) degree from an accredited law school.
- Minimum of 8-10 years of legal experience in the pharmaceutical or biotech industry, with a focus on clinical contracts and R&D.
- Admission to practice law in at least 1 state.
