Medical Director/Senior Medical Director, Medical Affairs (Remote

Philadelphia, PA

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 Vice President, Medical Affairs, we are seeking a highly motivated and experienced Medical Director/Senior Medical Director to join our Medical Affairs team. The incumbent will play a crucial role in shaping and executing the medical affairs strategy to support the company’s objectives and ensure the appropriate dissemination of medical information to various stakeholders.

Responsibilities:

Develop and implement a comprehensive Medical Plan aligned with the company’s goals and objectives including strategic plans for key opinion leader engagement, data dissemination, publications, and congresses.
Identify and seek input from thought leaders on emerging science in cell therapy and autoimmune diseases.
Provide medical leadership and guidance to cross-functional teams, including Medical Science Liaisons (MSLs), Clinical Development, Regulatory Affairs, and Commercial Teams.
Collaborate with internal stakeholders to develop evidence-generation plans, including clinical trials, real-world evidence studies, and health economics outcomes research (HEOR) initiatives.
Serve as a key point of contact for external stakeholders including but not limited to healthcare professionals, external experts, and key opinion leaders (KOLs) to provide scientific and medical support.
Support the identification and relationship development with investigators in clinical trials.
Connect with key patient advocacy organizations and establish ongoing collaboration.
Lead the development and execution of medical education and communication programs, including advisory boards, symposia, and scientific publications.
Partner and collaborate across functional areas to integrate a medical perspective into the development and commercialization process.
Ensure compliance with regulatory guidelines, industry standards, and company policies in all medical affairs activities.
Stay abreast of the latest scientific and clinical developments in relevant therapeutic areas to inform strategic decision-making.
Provide medical insights and input into product lifecycle management, including product launch strategies and lifecycle planning.
Contribute to the development and review of medical affairs materials, including medical information documents, scientific presentations, and medical education materials.
Mentor and support junior members of the Medical Affairs team, fostering a culture of continuous learning and professional development.

Qualifications:

Advanced scientific degree (MD, PhD, PharmD) and 5 years in an autoimmune disease area is required.
Minimum of 10 years of experience in US and/or Global Medical Affairs with strong preference in Immunology, Rare Diseases, and/or Cell Therapy.
Proven track record of developing and executing medical affairs strategies to support product development, launch, and lifecycle management.
Experience in field strategy and execution in Immunology and/or Rare Diseases is preferred.
Strong understanding of clinical trial design, real-world evidence generation, and health economics outcomes research.
Excellent communication and presentation skills, with the ability to effectively communicate complex scientific and medical information to diverse audiences.
Demonstrated leadership abilities and the ability to collaborate effectively with cross-functional teams.
Experience in a customer-facing role with thought leaders, scientific organizations, and patient advocacy groups.
Self-motivated, innovative, and critical thinker with hands-on execution with strong commitment to follow up on action items.
Thorough knowledge of regulatory requirements and compliance standards governing medical affairs activities.
Willingness to learn new therapeutic areas and technologies.
Strategic mindset with the ability to analyze data, identify insights, and translate them into actionable strategies.
Thrives in a fast-paced, small company environment and is able to adjust priorities and workload based upon changing needs.
Ability to travel domestically and internationally 25%, as needed.
Strong team orientation and passion for continuous self-development.
Experience in the biotech industry or in a startup industrial setting is preferred.

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.