Manager or Sr. Manager, Translational Medicine

 

Hybrid - Philadelphia

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn.

 

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®

Manager or Sr. Manager, Translational Medicine

Hybrid - Philadelphia

 

About the position:

The Manager or Sr. Manager, Translational Medicine will report to the Director, Translational Medicine and will be responsible for leading key external vendor relationships, budgeting for external workstreams, and planning for new translational workflows within existing or new clinical programs. They will work closely with the operations team within the Translational group to support ongoing testing requests at external vendors. Additionally, they will assist in the authoring, data verification, and timeline management of early phase regulatory submissions.

Responsibilities:

  1. Lead new vendor selection and manage ongoing vendor relationships necessary to support early phase and registrational clinical trials in the United States and within ex-US countries. Align heavily with Clinical Operations, Clinical Development, Regulatory Affairs and Quality Assurance on these partnerships.
  2. Establish new and manage existing vendor contracts and alliance to drive development of ongoing and future trials.
  3. Identify and vet novel translational vendors to support assay transfer and manage bespoke assay development.  
  4. Manage translational vendor relations and strategy across US and ex-US sites to ensure compliance and consistency across regulatory and quality.
  5. Support bespoke and annual regulatory submissions supporting early Phase clinical programs within the US and ex-US. Where necessary, support new clinical trial protocol development alongside the Clinical Development and Regulatory teams at Cabaletta.
  6. Working closely with subject matter experts within the Translational Medicine scientific team, facilitate technology transfer of key correlative assays from Cabaletta to external vendors. Oversee timelines and execution of assay validation, data generation, data transfer processes, and data interpretation.  
  7. Collaborate with cross-functional clinical operation study teams to ensure the successful execution of clinical studies and the timely delivery of high-quality study results.
  8. Attend scientific conferences, meetings, and workshops to keep up to date with the latest developments in the field of translational medicine, vendor management and contribute to scientific publications.

 

Qualifications:

  • MS/PHD in a relevant field along with a minimum of 3+ years of relevant experience in the pharmaceutical or biotech industry or BS with a minimum of 5+ years of relevant experience.
  • Strong understanding of drug development and clinical trial design, as well as experience in the interpretation and analysis of translational data.
  • Prior hands-on experience with vendor management, contracting, legal discussions, and financial planning.
  • A basic understanding of the regulatory process in the US and EU, is preferred. 
  • Excellent leadership, communication and interpersonal skills, and the ability to work effectively in a cross-functional team environment.Top of Form
  • Strong team orientation, collaborative skills, and passion for continuous self-development.
  • Experience in industry or in a startup industrial setting is preferred.
  • Background or relevant work experience in immunology or cell therapy is preferred.
  • High level of flexibility to support various other activities the ability to learn new techniques outside of existing field of expertise is ideal.
  • Highly motivated self starter

 

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.

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