Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching targeted, potentially curative, cellular therapies for patients with autoimmune diseases. The CABA™ platform includes two strategies to treat and potentially cure many of the most common and challenging autoimmune diseases. The CARTA strategy, or Chimeric Antigen Receptor T cells for Autoimmunity, is designed to potentially reset the immune system by causing transient B cell depletion with early academic clinical data suggesting the potential of this strategy to transform treatment in patients with SLE and the possibility of cures in rheumatoid arthritis, myositis, and systemic sclerosis, among others. Our lead product candidate using the CARTA strategy is CABA-201, 4-1BB-containing CD19-CAR T designed specifically to treat patients with autoimmune diseases with high unmet need, including systemic lupus erythematosus (SLE), myositis, systemic sclerosis, and generalized myasthenia gravis, and which uses a CD-19 binder that has an encouraging clinical tolerability profile. In addition to our CARTA candidate, CABA-201, we have a clinical-stage pipeline of Chimeric AutoAntibody Receptor T (CAART) cells targeted to the cells responsible for autoantibody-mediated autoimmune diseases.  Cabaletta Bio’s headquarters are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and follow us on LinkedIn and 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 Chief Medical Officer, the Senior Director Medical Affairs will provide scientific/medical leadership and support for programs in various stages of clinical development. This individual will take a leadership role for the development and execution of the Medical Affairs strategy in support of Cabaletta projects with representation on relevant cross-functional teams. They will serve as an autoimmune disease expert in content creation, strategic and tactical discussions, and presentations with internal colleagues, as well as external experts and investigators.

Responsibilities:

• Lead the Medical Plan development and execution.


• Provide scientific and clinical input into the development of disease strategy, and the development strategy including the non-registrational data generation plan (Phase IV), as applicable.


• Identify and seek input from thought leaders on emerging science in drug and biomarker research, disease knowledge and design of clinical protocol and programs.


• Develop thought leader engagement plan.


• Support the identification and relationship development with investigators in clinical trials.


• Connect with key patient advocacy organizations and establish an ongoing collaboration.


• Lead the organization and coordination of activities at various scientific congresses and meetings across multiple therapeutic areas.


• Develop and review key content for congresses, manuscripts, FAQs and medical standard response letters.


• Develop and execute strategic publications plan.


• Provide data dissemination via data rollout plans and training.


• Provide strategic insight into launch activities planning, and execute pre-launch, peri-launch and post-launch tactics.


• Partner and collaborate across functional areas to integrate a medical perspective into the development and commercialization process.


• Drive investigator sponsored research review, as applicable.


• Partner in the development and execution of health outcomes and access strategy.


• Provide medical review of asset content to align with overall strategy.

Qualifications

• Advanced scientific degree (MD, PhD, PharmD) and 10+ years in autoimmune disease area


• Relevant industry experience in Medical Affairs or Clinical Development.


• Experience in leading, growing and developing a Medical Affairs organization.


• Self-motivated, innovative, and critical thinker with hands on execution, and strong commitment to follow up on action items.


• Experience in a customer-facing role with thought leaders, scientific organizations, and patient advocacy groups.


• Experience working in a cross functional team including colleagues in clinical, marketing, access and health outcomes.


• Excellent analytical skills and solid experience in translating medical/clinical information into medical affairs strategies.


• Proficiency in scientific and clinical data review and interpretation.


• Highly organized and motivated individual possessing excellent communication, presentation and interpersonal skills.


• Strong team orientation and passion for continuous self and team development.


• Strong leadership and influencing skills with the ability to create a clear sense of direction.


• Ability to multi-task and willingness to flexibly lead; willingness to learn new therapeutic areas and technologies.


• Thrives in a fast-paced, dynamic small company environment and able to adjust priorities and workload based upon changing needs.


• Possess experience creating and managing budgets.


• Ability to travel 25%.
  
  

Other Qualifications

• Experience in the conduct of clinical trials through approval and commercialization in autoimmune disease preferred.


• Experience with mining databases and other bioinformatics skills a strong plus.
  
  

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.