Senior Director, Clinical and Regulatory Writing

 

Philadelphia, PA

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®

 

Position Description:               

 

This role can be remote, hybrid or based in our Philadelphia, PA headquarters.

The Senior Director, Clinical and Regulatory Writing will serve as a strategic leader within the Clinical, Medical and Regulatory organization, overseeing the development and delivery of high-quality regulatory and clinical documentation to support global regulatory submissions across the cell and gene therapy portfolio. This role partners cross-functionally with Regulatory, Quality, Clinical, Nonclinical, CMC, and external collaborators to ensure clear, compliant, and scientifically sound communication with regulatory agencies and other stakeholders. The Senior Director will lead a small team and be a key contributor to global regulatory strategy, content planning and drafting for regulatory designations, clinical updates and clinical modules of the BLA/MAA.

 

Responsibilities:

  • Lead the clinical writing function in the development, review, and approval of regulatory documents to support global submissions (e.g., INDs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Investigator Brochures, protocols, clinical study documents, PSPS/POIPs, Prime, RMAT)
  • Lead cross-functional content planning of regulatory submission modules, including data integration and interpretation, and ensuring consistency in strategic messaging for dossiers, meeting packages and responses to health authorities
  • Translate complex technical data from clinical and biostatistics teams into scientifically accurate, submission-ready documentation
  • Manage external consultants and contractors as needed to support Cabaletta submissions reviews, authoring, if needed, and gap analyses
  • Mentor, train, and manage a team of medical/regulatory/technical writers or cross-functional contributors in document development
  • Develop and implement strategic plans for medical writing activities, aligning them with clinical development, regulatory affairs, and overall business goals
  • Drive process improvements and develop standard practices for efficient, compliant and high-quality document delivery
  • Collaborate with Clinical Operations and external CROs to ensure inspection readiness of clinical trial documentation, including informed consents, study manuals, and IRB/IBC responses

 

Qualifications:

  • Advanced degree in life sciences (M.D., or PharmD preferred); MS, PhD with significant clinical pharmacology writing experience will be considered
  • 12+ years of progressive experience in regulatory or scientific/medical writing in the biopharmaceutical industry, including 5+ years in a leadership role
  • Demonstrated experience developing content for major global regulatory submissions (e.g., IND, BLA, MAA), preferably in cell or gene therapy
  • Strong understanding of drug development processes, regulatory frameworks (FDA, EMA, ICH), and clinical trial documentation requirements
  • Exceptional writing, editing, and analytical skills with the ability to convey complex scientific data clearly and persuasively
  • Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management
  • Proficiency in Microsoft Office Suite, document management systems (e.g., Veeva Vault), and electronic publishing tools
  • Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment
  • Collaborative mindset with the ability to influence and guide stakeholders across disciplines and levels of seniority
  • 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.

#LI-REMOTE