Associate Director / Director   - Clinical Program Management (Remote)

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and follow us on LinkedIn and X (Twitter).

 

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. 

We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great:  Working at Cabaletta Bio Inc | Great Place to Work®

 

About the Position:

Reporting to the VP, Portfolio & Program Management, the Associate Director /  Director, Clinical Program Management will support the planning, execution, and delivery of clinical programs and projects. This role involves coordinating activities, managing vendor relationships, and ensuring adherence to timelines and budgets. The ideal candidate will have 7+ years of experience in clinical trial oversight and project/program management, strong organizational skills, and proficiency in SmartSheet.

 

Responsibilities:

Project Coordination and Management:

  • Support the Clinical, Medical and Regulatory groups with extensive partnership with Clinical Operations, Clinical Development, Regulatory, and other team members, to develop and maintain project plans, timelines, and dashboards/trackers for multiple clinical programs in line with program, department, and corporate objectives.
  • Manage the Clinical Project Team (CPT) working with VP, Clinical Development and VP, Clinical Operations
  • Work extensively partnered with the lead Asset PM to support our cross-functional Product Development Team Program (PDT) and the CABA-201 clinical program.
  • Work with Regulatory Affairs and Medical Writing to integrate submission planning and writing activities with team objectives
  • Schedule and lead team meetings including developing agendas, publishing meeting minutes and decision logs, and tracking action items to completion.
  • Extensively support ongoing program management initiatives and PMO best practices by utilization and/or creation of project management tools and templates across the company
  • Initiate and maintain cross-functional collaboration and communication, as needed, to drive project progress and team alignment.
  • Support the generation of tools to support an overall company project portfolio and contribute to the PMO culture of continuous improvement
  • Identify, define, score, and communicate risks for each project/program as part of an overall risk register with risk mitigation and contingency plans, as required by Enterprise Risk Management (ERM) process
  • Work across time zones as necessary.
  • Travel (U.S.) 10-15% may be required.
  • Other duties as assigned.

 

Vendor Management:

  • Working cross-functionally, coordinate with vendors and external partners to track, manage, and escalate, as needed, ongoing and upcoming projects with a focus on on-time delivery.
  • Ensure project deliverables are met with required quality and timeline attributes.
  • Track vendor performance, manage contracts, and address issues as they arise while nurturing short-term and long-term positive relationships.
  • Facilitate communication between vendors and internal cross-functional teams including management of overall governance meetings with key vendors.

 

SmartSheet Management:

  • Utilize SmartSheet for project planning, tracking, and reporting both within a singular project and across multiple projects/programs creating one unified portfolio summary/report
  • Create, maintain, and publish SmartSheet dashboards and reports for project status updates.
  • Work with the PMO team to ensure that all department timelines and risk trackers integrate within the overall corporate portfolio and integrated roadmaps.
  • As SmartSheet Super User, train and support team members on SmartSheet use, management, and reporting as well as other functionalities, as needed.

 

Qualifications:

  • Bachelor’s degree in Life Sciences, Advanced degree is a plus.
  • 7+ years of experience in clinical trial/program management and project/program management experience, or a similar role.
  • Proficiency in MS Office (MS Outlook, PowerPoint, Excel, and Word); familiarity with project management tools is required.
  • Extensive experience in utilization of Smartsheet including creation, maintenance, and reporting of timelines, Gantt charts, dashboards, and reports.
  • Excellent external facing representation and experience in managing vendor relationships and contracts.
  • Excellent verbal and written communication skills.
  • Outstanding attention to detail with the ability to manage multiple tasks and priorities.
  • Ability to work both independently and collaboratively with cross-functional teams.
  • Thrives in a dynamic, fast-paced, timeline-based environment.
  • Strong customer service focus as part of a centralized PMO function.
  • Knowledge of clinical research processes and regulations is required.
  • Certification in project management (e.g., PMP, CAPM) is an advantage.
  • Experience in pharmaceutical or biotechnology industries is required.
  • Experience with both early- and late-stage clinical programs is an advantage.

 

Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.

For more information, please visit  https://www.cabalettabio.com/join-our-crew

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 based on 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.

Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.

And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.