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Associate Director – Director Clinical Operations

Philadelphia, PA

About the Position

Reporting to the VP, Clinical Operations, we are seeking an experienced and motivated Associate Director/Director, Clinical Operations.  Level will be determined by candidate’s experience.  The Associate Director/Director, Clinical Operations will be a proactive, self-starter who is responsible for providing management-level oversight and support to clinical operations vendors and teams in planning, conducting, and closing out of assigned clinical studies with a focus on quality and compliance.  This individual will also support Clinical Operations departmental projects including continual process improvement initiatives related to study management, information and tracking systems, metrics, cost and resource analysis, and the development of or enhancement of clinical operations SOPs, and may act as line-manager to assigned Clinical Operations staff.  Additionally, this individual will be a key contributor to the clinical development planning and analysis of data of assigned programs, including applying his or her experience to the development of protocols, data management, and statistical analysis plans.

Responsibilities Include

  • For assigned clinical studies, provides management-level oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development through study execution, close-out, analysis and reporting
  • Authoring study documents and plans
  • Developing strong relationships with and hands-on management of investigational sites and site monitors
  • Selection and management day-to-day activities of multiple vendors
  • Development and management of operational budgets for assigned studies
  • Acting as a liaison with other internal and external functional departments including quality assurance, data management, document management, regulatory, safety, translational research, clinical supply management, etc
  • Ensuring high quality and compliance of work products to internal SOPs and external regulations to avoid unacceptable risk to the projects and functional area
  • Utilization of project management analytical methods to assess progress and risks for assigned studies
  • Provides direct management and mentoring to assigned contract and permanent Clinical Operations staff (e.g., CRAs and CTAs). Assesses staff training needs and develops/coordinates training programs or identifies opportunities for training.
  • Supports Clinical Operations departmental projects including continual process improvement initiatives and SOP development

Required Qualifications

Education: minimum Bachelor’s degree. 

Knowledge Requirements:

  • Extensive knowledge of standard industry practices related to study planning, start-up, and execution including site management and monitoring, document management, data management, and clinical supply management.
  • General knowledge of other clinical trial functional areas and their respective deliverables including, regulatory affairs, safety, medical monitoring, and medical writing.
  • Working knowledge of GCP/ ICH regulatory guidelines

Experience/Skills:

  • Minimum 8 years clinical research experience
  • Minimum 5 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management
  • Minimum 3 years experience supervising clinical trial staff (contract or permanent)
  • Experience managing Contract Research Organizations and other external vendors (e.g., central laboratory vendor, etc.)
  • Strong attention to detail, good organizational and communication skills, ability to work independently and interact with senior management on a regular basis
  • Demonstrated leadership skills
  • Proficient with project management tools and analysis of metrics
  • Experience managing within a matrix management organization preferred
  • Management of global clinical trial strongly preferred
  • Cell/Gene therapy or oncology experience preferred

Special Information:

  • In-house position (currently 2-3 days on-site) with travel estimated less than 20%; however must have willingness to travel to meetings, study sites, and vendors based on study demands.

How to Apply

Please email careers@cabalettabio.com directly to submit an application.

Please include your CV along with the title of the position you are applying for.

Benefits

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

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.

About Cabaletta Bio

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, and initial safety data in clinical trials has been reported. 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. Cabaletta Bio is also pursuing additional pipeline candidates for other B cell mediated disorders including MuSK Myasthenia Gravis (MG) with an IND planned for 2H 2021, mucocutaneous PV, PLA2R positive membranous nephropathy (PMN), and Factor VIII inhibitors.

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