Senior Director, Assistant General Counsel

Valid8 Financial, Inc.; Philadelphia (Philadelphia County); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive benefits

Stock option plans

Paid time off (PTO)

Job summary

Cabaletta Bio in Philadelphia, PA, seeks a Senior Director, Assistant General Counsel to partner with Clinical Operations, Medical Affairs, Research and Commercial in a hybrid work setting.

You will translate complex legal and regulatory requirements into practical business guidance, negotiate across the U.S., Canada, EU and UK, and help shape the company’s compliance program with a focus on risk-based counsel.

Qualifications

• Juris Doctor degree with 8+ years of general corporate legal experience in biotechnology and/or pharmaceutical industries.
• 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.

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, 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, including 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.

Skills

Strategic thinking

Cross-functional collaboration

Regulatory compliance

Education

Juris Doctor degree

Job description

Job Description – Senior Director, Assistant General Counsel – Hybrid, Philadelphia, PA

Philadelphia, PA

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. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn.

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew.

About the Position: Hybrid/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 and Manufacturing and other cross-functional stakeholders, enabling efficient decision-making while appropriately managing legal and compliance risk. The Senior Director, Assistant General Counsel 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, 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, including 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 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.

Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long‑term immunosuppression.

Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.