Sr. Director/VP of Regulatory Affairs

Philadelphia, PA

Cabaletta Bio (NASDAQ: CABA) is focused on the discovery and development of T cell therapies for B cell-mediated autoimmune diseases. Our proprietary technology utilizes Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to precisely bind and destroy only specific autoantibody-expressing B cells while sparing normal antibody-expressing B cells, which are essential for human health. Cabaletta’s Approach for selective B cell Ablation platform, called our CABA™ platform, has applicability across more than two dozen B cell-mediated autoimmune diseases that we have identified, reviewed and prioritized. CAAR T technology is based on the revolutionary Chimeric Antigen Receptor (CAR) T cell technology developed at the University of Pennsylvania that resulted in one of the first commercially-available CAR T cell products for the treatment of B cell malignancies. Cabaletta has an exclusive global licensing agreement and multiple sponsored research agreements with the University of Pennsylvania to develop CAAR T technology to treat B cell-mediated autoimmune diseases.

The Company’s lead product candidate, DSG3-CAART, received IND clearance from the FDA in September 2019. DSG3-CAART is designed to be a potential treatment for patients with mucosal pemphigus vulgaris (mPV), which is a rare autoimmune blistering disorder that causes painful blisters and sores on mucous membranes leading to severe and sometimes debilitating and life-altering effects. The Company is expected to begin clinical trials for the lead compound for mPV in 2020. Cabaletta Bio is also pursuing a second product candidate, MuSK-CAART, designed to treat patients with MuSK-positive Myasthenia Gravis.

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing a new type of therapy, where patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that success in the Cabaletta mission lies in the hands of individuals across every aspect of the company. To nurture this, we make an active commitment to the well-being and continuous growth of each person who joins our team.  In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew

About the Position

Reporting to the Chief Medical Officer, the Sr. Director/VP of Regulatory Affairs will be responsible for driving the success and strategy of our regulatory affairs function. The role will be responsible for driving the Regulatory Affairs functional perspective as Cabaletta Bio makes important early decisions about nominating development candidates and building a diverse pipeline of future programs, as well as the continued development of current programs through the clinic. The focus will be on driving programs to an IND submission and early clinical development activities after IND approval.

Responsibilities include to:

  • Develop and implement regulatory strategic plans and present recommendations to the Management Team, Board, and other advisory groups related to product development, study design, and acceleration opportunities
  • Act as the regulatory lead by providing deep expertise to programs from pre-clinical to early clinical to end of Phase II as well as support for CMC activities
  • Manage regulatory aspects of products and projects, including timelines and deliverables
  • Provide innovative and proactive regulatory leadership to project teams that align with the development plan and corporate goals
  • Coordinate, prepare and draft responses to questions, requests for information from regulatory authorities
  • Prepare meeting requests, briefing documents, and lead teams for interface with regulatory authorities, focused largely on pre-clinical and early clinical interactions
  • Plan, prepare, and review submissions to regulatory authorities (FDA, EMA, etc.) and other major national regulatory authorities to support the conduct of clinical trials and approval of marketing applications, including but not limited to IND, CTA, BLA, and MAA
  • Ensure accuracy of regulatory documentation and compliance with major applicable regulatory authorities
  • Manage contract staff and vendors as needed to support regulatory activities

Required Qualifications

  • B.A./B.S. or higher degree in a science-related discipline with 10 + years of regulatory affairs experience in the pharmaceutical or biotechnology space, guiding regulatory strategy for innovative, novel biologics
  • Extensive experience engaging regulatory agencies from early pre-clinical development through IND/CTA
  • Demonstrated track record with regulatory agencies in creating a path for novel biologics to advance into and through the clinic and ultimately leading to regulatory submissions
  • Deep knowledge of regulatory requirements and environment
  • Thorough knowledge of relevant FDA regulations related to cGMP manufacturing environments
  • Thorough understanding of the drug development process including CMC challenges and strategies supporting expedited drug development pathways for rare diseases and novel therapeutics
  • Excellent oral and written communications skills, in particular synthesizing complex data from multiple scientific and clinical sources to write well-organized and cohesive regulatory documents
  • Possess high learning agility and scientific curiosity
  • Strong attention to details, excellent organization skills, and proactive willingness to collaborate and contribute to the success of a team
  • Ability to thrive when working in a fast-paced, innovative environment requiring flexibility, strategic agility, and creativity
  • Demonstrated strategic thinking and implementation in overall drug development

Preferred Qualifications

  • Direct experience on early-stage cell therapy (or gene therapy) products, leading regulatory strategy within a small biotech environment, is highly preferred
  • Global experience is preferred, including interactions with FDA, EMA, and national authorities in major EU countries, but extensive experience with the FDA is required

Our name – Cabaletta – is derived from the operatic term for the second part of an aria that is designed to highlight the technical expertise of the lead singer. While our company is not the first to develop chimeric T cells as therapies, we are the first to develop them in a way that leverages T cells to specifically eliminate only B cells that cause disease, while sparing healthy B cells. Utilizing the backbone of this core technology, we expect to advance our portfolio with a rapid and repetitive rhythm, similar to the rhythm that is typical of a cabaletta.

For more information, please visit https://www.cabalettabio.com/ or email careers@cabalettabio.com directly to submit an application. Please include your CV along with the title of the position you are applying for.

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.