Vice President/Sr. Director., Associate General Counsel

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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Vice President/Sr. Director., Associate General Counsel

Cabaletta Bio