Senior Director, Assistant General Counsel

Cabaletta Bio · Philadelphia, PA · 1 wk ago

HybridFull-time

Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases.

About the Role

Hybrid role based in Philadelphia, PA. Reporting to the General Counsel, the Senior Director, Assistant General Counsel will serve as a trusted legal advisor and strategic business partner to Clinical Operations, Medical Affairs, Research, Commercial, Manufacturing, and other cross-functional stakeholders, enabling efficient decision-making while appropriately managing legal and compliance risk. This role brings a strong background in life sciences or biotechnology, with a demonstrated ability to navigate complex legal issues in a fast-paced and collaborative environment.

Responsibilities

Translate complex legal and regulatory requirements into practical, business-oriented advice for internal stakeholders.
Proactively support a broad range of functions within the Company, with a primary focus on Clinical Operations, Medical Affairs, Research, and Commercial.
Draft, review, and negotiate a wide variety of agreements including:
- Clinical trial agreements and related informed consent forms and protocols;
- Research and development agreements;
- Manufacturing and supply agreements;
- Consulting agreements;
- Service agreements; and
- Material transfer agreements for activities in the U.S., Canada, EU, and UK.
Provide legal support for certain commercial activities ahead of commercial launch, including serving as reviewer on promotional review committees and advising on compliance matters such as HCP engagements, speaker programs, advisory boards, grants, charitable contributions, sponsorships, consultant arrangements, and interactions with healthcare organizations.
Advise on U.S. privacy and EU/UK GDPR issues as they relate to clinical trial participant, patient, and employee data.
Collaborate with cross-functional teams to ensure regulatory compliance across relevant aspects of the business, including clinical trials, FDA regulations, GCP requirements, and healthcare compliance.
Support the development of Company policies and promote ethical practices; and support the implementation of the compliance program throughout the organization.

Qualifications

Juris Doctor degree with 8+ 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.
Demonstrated ability to provide pragmatic, risk-based legal guidance in support of business objectives.
Strategic thinker who translates complex legal and regulatory requirements into practical business guidance.
Strong team orientation with a demonstrated ability to build strong relationships across various business functions and a passion for continuous self-development.
Ability to manage multiple complex tasks with a focus on critical priorities.
Outstanding integrity and ethical conduct.
Solid understanding of the legal issues affecting the pharmaceutical industry, with a particular focus on clinical development, medical affairs activities, research collaborations, and regulatory processes for prescription drugs, anti-kickback, fraud and abuse, anti-bribery and anti-corruption, and antitrust laws.

Preferred Experience

Experience in industry or in a startup or growth-stage company setting.
Experience with promotional review committees.
Experience advising on employment-related matters and supporting HR functions.

Benefits