- Proactively support a broad range of functions within the Company, including Clinical Operations, Medical Affairs, Research, Manufacturing, Quality, Finance, Alliance Management and Business Development and Human Resources.
- Draft, review, and negotiate a wide variety of agreements including clinical trial agreements, license agreements, research and development agreements, manufacturing agreements and material transfer agreements.
- Review, analyze and keep current on relevant legal developments affecting the pharmaceutical and biotech industries.
- Provide strategic legal advice and counsel to senior management on corporate governance matters, SEC reporting requirements, and stock exchange compliance.
- Collaborate with cross-functional teams to ensure regulatory compliance across all aspects of the business, including clinical trials, FDA regulations, and healthcare compliance.
- Support the development of Company policies and promote ethical practices; and support the implementation of the compliance program throughout the organization.
- Advise on U.S. privacy and EU / UK GDPR issues.
- Advise on legal aspects of the Company's financing activities and corporate structure considerations.
- Support the General Counsel in the management of the intellectual property portfolio, including patents, trademarks, and trade secrets, and provide guidance on IP strategy and enforcement.
- Juris Doctor degree with 10+ years of general corporate legal experience in biotechnology and/or pharmaceutical industries in either in-house, private practice or a combination of both.
- 3+ years in practice with an established law firm preferred.
- Solid understanding of the legal issues affecting the pharmaceutical industry, with a particular focus on early-stage research and innovation, research collaborations, licensing as well as regulatory processes for prescription drugs, anti-kickback, fraud and abuse, anti-bribery and anti-corruption and antitrust laws.
- In-depth understanding of the pharmaceutical industry, including Clinical, Manufacturing, Intellectual Property, Quality, R&D, regulatory and commercial elements.
- Experience with corporate governance issues and corporate secretarial duties preferred.
- Ability to manage multiple complex tasks with a focus on critical priorities.
- Demonstrated experience collaborating across multiple business functions in order to accomplish complex tasks.
- Outstanding integrity and ethical conduct
- Strong communications skills (both written and oral), with ability to explain complex legal issues to the Leadership Team in order to facilitate decision-making.
- Strong team orientation with a demonstrated ability to build strong relationships across various business functions, and a passion for continuous self-development.
- Experience in industry or in a startup industrial setting is preferred.
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