Sr. Director/Vice President Clinical Operations
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, we are seeking an experienced and motivated Senior Director/Vice President of Clinical Operations with responsibility for strategic oversight and operational leadership of clinical trials conduct. Key responsibilities will be building and leading the clinical operations function, including study planning, financial oversight, vendor management, trial timeline management, and ensuring GCP compliance. The position requires a leader with significant experience working with CROs and interacting with investigator sites, to ensure operational efficiency and effective execution of trials within a complex environment.
Responsibilities include to:
- Demonstrates a high level of expertise with operational processes and requirements, and effectively applies this knowledge to lead the clinical operations function to achieve corporate objectives
- Accountable for successful execution of clinical studies and programs to meet pertinent timelines and clinical milestones. Develops the clinical operations strategy including risk management and contingency planning
- Establishes, monitors and reports on performance standards and metrics for the execution of clinical projects with a focus on proactive identification of issues and implementation of appropriate corrective actions
- Understands the patient journey in clinical trials and potential patient safety and logistic issues to optimize recruitment strategies
- Identifies and implements innovative solutions to resolve roadblocks in patient recruitment and clinical trial execution
- Builds relationships with the investigators/site personnel and the CROs/other contractors to drive effective communication and collaboration for successful clinical trials execution
- Owns clinical operations budget and provides forecasts and monitoring of budgets across all clinical programs for near term and long-range planning; develops accurate assumptions and prudent allocation of resources
- Identifies, evaluates, selects, manages and provides oversight of CROs/other contractors. Primary point of contact for escalation of issues including development of risk mitigation strategies as appropriate.
- Utilizes robust and creative approaches to maximize the value of CRO activities with a rigorous approach on budgetary control
- Implements best practices and standards for trial management in collaboration with other members of the clinical team, including establishment of SOPs
- Collaborates with Quality Assurance, Regulatory, and Clinical to ensure that clinical trials meet compliance, regulatory, and patient safety requirements
- Establishes and maintains strong partnerships with CRO’s, partners, vendors and external stakeholders.
- Provides mentorship and career development to direct reports.
- 7-10+ years of direct experience in clinical drug development setting and at least 5 years of prior management/supervisory experience. Expertise in the oversight of clinical trials with demonstrated focus on enterprise performance to bring value and efficiencies to an organization
- Bachelor’s Degree in life sciences is required; advanced degree (masters or doctorate level) is preferred
- Cell therapy experience highly desired
- Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
- Strong experience in vendor management, leading CROs/various contracted resources, site monitoring and clinical quality compliance, and managing clinical trial budgets and clinical finance activities
- In-depth knowledge of GCP guidelines and FDA regulations and clinical operations development processes.
- Strong communication and influence skills and ability to create a clear sense of direction
- Comfortable in a fast-paced small company environment and able to adjust priorities and workload based upon changing needs
- Comfort with ambiguity and ability to define processes and procedures from scratch
- Successful candidates will have a strong team orientation and passion for continuous self-development.
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 including a selection of medical, dental, vision plans, 401K match, transportation stipends, 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.