Director, GCP Quality & Compliance Program

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

The Director of the Clinical Research Compliance Program is an integral member of the GxP Quality and Compliance team. The Position is responsible for implementing and maintaining a clinical quality and compliance program and operationalizing the components of the program in alignment with applicable laws and regulations and Cabaletta Bio SOPs and policies.

About the Position

The Director of GCP Quality & Compliance Program, reporting to the VP of Quality & Compliance, is responsible for directing Cabaletta Bio’s GCP Compliance Program to ensure regulatory compliance across Clinical Operations and provide senior level expertise and oversight for quality systems regarding all GCP activities. The Director will provide recommendations for clinical research best practice to the Clinical Development team. The role will require up to 20 – 40% travel.

The GCP Compliance Program consists of setting best practices for clinical research conduct, contributing to the education of employees, providing CRO oversight, communicating effectively with other related teams and auditing of clinical research activities for GCP compliance and adherence to management plans. Responsible for risk management activities for Cabaletta Bio clinical trials, including leadership and contribution to the development of risk management and corrective action plans.

Responsibilities include to:

  • Lead the strategic planning, creation and implementation of the standardization for all compliance program activities and standard operating procedures across Cabaletta Bio.                
  • Responsible for management, training, and the auditing activities of internal monitoring and vendor qualification and management, including providing oversight and leadership of auditing schedules, the conduct of audits, review of compliance reports, adherence to protocol Data Safety.
  • Monitoring Plans, Audit SOPs and identification of areas of risk and incorporation of risk mitigation plans into quality and compliance activities.          
  • Facilitate external audits, regulatory inspections, including FDA, escalation procedures as applicable.                
  • Author and/or contribute to SOPs regarding the conduct and oversight of clinical trials, including auditing.   
  • Oversee and report on the management and compliance of clinicaltrials.gov submissions.
  • Quality management and oversight of Trial Master File (TMF)

Required Qualifications

  • Requires a bachelor’s degree in biomedical science, regulatory affairs, clinical research, nursing or related health sciences degree.
  • At least 10 years of clinical research experience with increasing responsibilities in one or more of the following areas, Pharmaceutical Industry, Contract Research Organization or Site Management Organization.
  • Experience with FDA/federal agency inspections highly preferred.
  • A minimum of 5 years of previous monitoring or auditing experience required.
  • Advanced knowledge of federal research regulations and guidance, including but not limited to 21CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46 and ICH GCP guidance
  • Superior interpersonal and leadership skills with the ability to build and maintain effective professional relationships.
  • Ability to provide clear, pragmatic direction and advice regarding compliance issues.

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.