Cabaletta Bio Philadelphia , PA 19107
Posted 2 weeks ago
Vice President/Sr. Director., Associate General Counsel
Philadelphia, PA
About the Position
Reporting to the General Counsel, the Associate General Counsel will be responsible for providing practical, timely, strategic legal advice across a broad range of complex legal matters and supporting the General Counsel and a broad spectrum of business functions. The successful candidate will possess a strong background in life sciences or biotechnology, with a demonstrated ability to navigate complex legal issues in a fast-paced and collaborative environment. Title will be Senior Director or Vice President based on experience. This role can be either hybrid or remote, based on candidate location.
Responsibilities Include
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.
Required Qualifications
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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Cabaletta Bio