Job Details

Medical Director/Senior Director, Clinical Development

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:


We are looking for a Sr. Manager/Associate Director, Supply Chain Operations – International to join our team, reporting directly to the Vice President, Supply Chain Operations. You will oversee and optimize our international supply chain operations, ensuring seamless integration and compliance. Your role will involve supporting the selection and management of Clinical Treatment Centers, developing trade compliance policies, and collaborating with cross-functional teams to enhance business systems.


As the subject matter expert on the CAR-T "vein-to-vein" supply chain for ex-US patients, you will work with third-party providers to streamline drug product delivery and support clinical operations. Your strategic insights will help shape our supply chain innovations and enable Cabaletta to scale manufacturing from early to late clinical development until commercialization


Responsibilities:


Supply Chain Setup




  • Support the selection, onboarding, qualification and contracting of Clinical Treatment Centers outside the US.

  • Provide expertise on both the physical and financial flows of materials across the supply chain. 

  • Support Cabaletta stakeholders in establishing ex-US operations, translating preferred financial flows into operational processes, and managing import/export activities.

  • Develop, implement, and maintain trade compliance policies and procedures aligned with evolving regulatory requirements.





  • Design and manage a robust framework to support cross-border clinical and future commercial activities outside the US.

  • Oversee accurate product classification, country of origin determination, selection of preferred incoterms, and ensure compliance with VAT and tax regulations in collaboration with the International Finance team.

  • Establish, roll out and embed processes and tools to enable effective and smooth operations between Cabaletta, its Partners and the Treatment Centers, as well as internal operations, driving continuous enhancements.

  • Collaborate with cross-functional teams to develop, roll out, maintain and enhance critical business systems and tools (e.g., ERP, traceability tools). 



Supply Chain Operations




  • Act as Cabaletta’s subject expert matter on the “vein-to-vein” supply chain for ex-US patients.

  • Collaborate with 3rd party providers: customs broker, courier, IOR/EOR representative, cryopreservation sites, CDMO’s, clinical sites) to streamline drug product delivery to patients.

  • Partner with the internal Treatment Center Readiness team to ensure a smooth start of clinical operations.

  •  Align cross-functional teams (internal and external) through timely and effective communication.

  • Lead and manage trade compliance programs, ensuring adherence to international trade regulations.





  • Facilitate and lead cross-border trade operations, ensuring efficient product movement across Cabaletta’s supply chain.

  • Conduct thorough reviews of shipping and customs documentation, both pre- and post-shipment, to ensure accuracy and compliance.

  • Act as the Finance – Supply Chain liaison, integrating the ex-US demand forecast into the Global demand planning to optimize the patients’ treatment planning.




 



Supply Chain Strategy



  • Support the ex-US CDMO future strategy.

  • Contribute to the short, mid and long-term strategy enabling Cabaletta to scale manufacturing across clinical phases (I,II,III) and commercialize products.

  • Identify and support the next wave of supply chain innovations in CAR-T.

  • Monitoring our key competitors supply chain operations ex-US.


 


 


Qualifications:




  • Bachelor's degree or the combination of education and business experience required.

  • 6+ years relevant experience (e.g. Supply Chain or Trade Compliance) in the biotech and/or pharmaceutical industry required, ideally in cell and gene therapy.

  • Experience managing a Trade Compliance function in Europe and International.

  • Experience transitioning from clinical development to commercial environment is desirable.

  • Excellent communication and presentation skills are necessary.

  • Experience managing cross functional initiatives and building and implementing processes.

  • Experience with clinical operations.

  • Approximately 25% travel may be required.

  • Highly self-motivated individual, with demonstrated ability to work independently in a fast-paced and complex environment.



 


Location: This position is based in Switzerland (potentially Germany), fully remote work with travel estimated up to 25%.


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 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.


 


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.


#LI-REMOTE


 
Philadelphia
Biotech/Pharmaceutical
Clinical
Full-time
Director
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