Director/Senior Director of R&D Operations
Cabaletta Bio is focused on the discovery and development of T cell therapies for B cell-mediated autoimmune diseases. Cabaletta’s therapeutic platform produces highly selective autologous Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to precisely bind and destroy only specific autoantibody-producing B cells while sparing normal antibody-producing B cells, which are essential for human health. The platform 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 the CAAR T technology to treat B cell-mediated autoimmune diseases. The Company’s lead therapeutic program is a potential treatment for a prototypical B cell-mediated autoimmune disease, mucosal pemphigus vulgaris (mPV), which is a rare skin disorder that causes painful blisters and sores on mucous membranes leading to severe and sometimes debilitating and life-altering effects.
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 EVP of Science & Technology, the Director or Senior Director of R&D Operations will oversee planning, budgeting, integrating, tracking, and communicating cross-functional activities for Cabaletta Bio’s product development programs, ranging in scope from pre-clinical through to commercialization. This will include working with internal stakeholders, academic partners, and external vendors.
Responsibilities include to:
- Provide effective leadership and direction for cell therapy development programs.
- Work closely across all functional areas within Sciences/Technology Research & Development, Clinical Development, Manufacturing and Preclinical Research to develop, set and coordinate strategies related to cell therapy development.
- Serve as a liaison between functional areas in order to facilitate the advancement of cross-functional research projects / programs through the pipeline.
- Coordinates and facilitates communication between functional areas and stakeholders such as academic collaborators, vendors or corporate partners, where applicable.
- Drive contracting process with vendors and collaborators working closely with internal stakeholders.
- Nurtures productive relationships with internal and external customers. Ensures quality and timeliness of deliverables for the projects are met.
- Initiates and coordinates the decision-making and risk-management process including trouble shooting and is proactive in dealing with vendor / collaborator issues.
- Ensures effective, accurate and timely communication across functional areas within the project / program, serving as a primary point of contact among functional areas for project / program-related issues.
- Identifies and implements cross-project best practices in order to facilitate standardization and coordination across disciplines, functions and/or programs.
- Assesses project issues and develops solutions to meet productivity, quality goals and objectives.
- Develops tools and mechanisms for monitoring progress and problem solving with line managers. Defines and documents working / best practices that can be used across other projects
- Creates and maintains all project timelines and is responsible for communicating changes to the approved plan.
- Establishes scopes of work, leads the delivery of project milestones in a timely fashion and within project management standards.
- Coordinates and tracks the status of cross-functional communication and integration activities.
- Ensures timely supply of preclinical, manufacturing and clinical material to meet regulatory and commercial deadlines.
- Implements a tracking and planning system for manufacturing supply of drug substance and drug product.
- Supports the planning and execution of technology transfers, risk management, qualification, validation, resource allocation, and training.
- Proactively communicates risks, critical path items and status, and feedback to the EVP and across senior leadership.
- PhD in Biological Sciences or related fields with 5 + years’ experience, M.S. with 7 + years of experience, or B.S with 10 + years of experience working within biologics development and project management within the biotechnology industry.
- Ability to work independently and adapt to various personality types.
- Excellent written and oral communication skills.
- Working knowledge of regulatory requirements, including good working knowledge of GMP and ICH regulations.
- Contract management experience when working with CROs, CMOs, and CDMOs.
- Ability to operate in a fast-paced environment.
- Highly organized and efficient, with a curiosity to be part of cutting-edge science.
- MBA or PMP certification
- PhD in Biological Sciences preferred
- Background in cell or gene therapy discovery, development, or manufacturing.
- Experience in a start-up environment or wearing multiple hats within an organization.
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 firstname.lastname@example.org 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.