Director/Senior Director, Global Compliance Risk Management

Philadelphia, PA, United States

Senior Director/Director, Global Compliance Risk Management

Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio's headquarters and labs are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and follow us on LinkedIn and X (Twitter).

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.

We're proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work®

This role is located in Center City, Philadelphia. We are a hybrid work environment, and the expectation is that this role will be in the office 1-2 days per week, with the remainder of the week remote.

As we expand our global footprint, we are seeking a highly skilled and experienced Senior Director/Director of Global Compliance Risk Management to lead our compliance efforts and ensure we meet regulatory standards across all markets. This role will report into our Chief Compliance Officer.

This role will be responsible for developing, implementing, and overseeing the company's global compliance programs. This role requires a strategic thinker with deep knowledge of regulatory requirements in the biotech industry, particularly in cell therapy. The ideal candidate will be adept at managing risk, ensuring regulatory adherence, and fostering a culture of compliance throughout the organization.

Key Responsibilities:

Develop and implement a comprehensive enterprise risk management program tailored to the unique needs of Cabaletta Bio.

Ensure the company's compliance with all relevant regulations and standards across different markets, including FDA, EMA, and other international regulatory bodies.

Lead the development and maintenance of policies and procedures that promote compliance and mitigate risk.

Conduct regular risk assessments and audits to identify potential compliance issues and implement corrective actions.

Oversee the development and delivery of compliance training programs for employees at all levels.

Act as the primary point of contact for regulatory agencies and manage all compliance-related communications and reporting.

Collaborate with cross-functional teams, including legal, regulatory affairs, quality assurance, and clinical operations, to ensure a cohesive approach to compliance.

Monitor changes in regulatory requirements and update compliance programs accordingly.

Develop and maintain a compliance risk management dashboard to track key performance indicators and report to senior management.

Lead investigations into compliance violations and oversee the implementation of remedial actions.

Foster a culture of ethical behavior and compliance throughout the organization.

Required Skills and Experience: Bachelor's degree in Life Sciences, Law, Business, or a related field; Advance degree preferred

Minimum of 10 years of experience in compliance risk management within the biotech or pharmaceutical industry, with a strong preference for experience in cell therapy.

In-depth knowledge of global regulatory requirements, including FDA, EMA, and other international standards.

Proven track record of developing and implementing effective compliance programs.

Strong analytical and problem-solving skills with the ability to assess complex regulatory requirements and develop practical solutions.

Excellent communication and interpersonal skills, with the ability to influence and engage stakeholders at all levels.

Demonstrated leadership and team management skills, with experience leading cross-functional teams.

Ability to work independently and manage multiple priorities in a fast-paced environment.

Professional certifications in compliance or risk management (e.g., CCEP, CRMA) are highly desirable.

Strong team orientation and passion for continuous self-development.

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.

For more information, please visit https://www.cabalettabio.com/join-our-crew

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.

Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.

And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.