Description:
This Counsel will become a key partner to support clinical research in the development of novel medicines with a remarkable impact on patients. The Counsel, Clinical R&D, will be an integral part of a team of attorneys and paralegals providing strategic legal and business advice in support of An American Publicly Traded Biopharmaceutical Company's Global R&D organization. For candidates with strong leadership and strategic thinking skills, this role provides the opportunity to work cross-functionally with research and development teams and other corporate functions, including intellectual property, litigation, global privacy and ethics and compliance. In this role, the Counsel will be expected to interact regularly and effectively with management, internal business stakeholders, and third-party partners. They must be creative, strategic, and innovative while negotiating and managing complex contracts and be focused on bringing matters to timely and successful conclusion.Responsibilities:
The Counsel, Clinical R&D, will be responsible for identifying and resolving complex legal issues and drafting and negotiating agreements. The responsibilities of the Counsel, Clinical R&D, will include:
- Clearly communicating advice on complex situations that may arise related to clinical research including patient privacy and rights, data integrity, site and investigator non-compliance, fraud and abuse matters and digital health.
- Drafting, reviewing and negotiating a wide variety of agreements including clinical study and collaborative research agreements, service provider agreements in support of our clinical trial operations and other transactional and complex R&D agreements with research partners.
- Developing patient informed consent forms for use in clinical research and incorporating feedback from regulatory authorities and/or ethics committees.
- Providing clear advice to clients, including legal leadership, ensuring that advice maximizes the potential of our pipeline.
- Serve as recognized source, for both management and other attorneys, of innovative ideas in complex areas of law, business, technology or research.
Qualifications:
- Law degree from an ABA accredited law school and in good standing with the state bar of the jurisdiction in which your office will be located (or ability to gain licensure in the state in which your office will be located)
- 5 + years of relevant experience with some in-house experience preferred.
- Experience in advising on R&D matters, such as clinical trials.
- Ability to support the achievement of pharmaceutical business objectives by providing clear and practical counsel, including evaluating and managing risk.
- Ability to use legal training to maximize business opportunities.
- Have excellent transactional drafting and legal analysis skills, be a crisp, concise communicator and have the ability to identify and quickly address critical issues.
