Cabaletta Bio Inc.

Senior Vice President, Sales & Marketing

Cabaletta Bio Inc. · Full Time · 4 days ago

Cabaletta Bio Inc.

🌎 United States ⭐ 10+ yrs exp 💼 Sales

The Senior Vice President will lead the Sales and Marketing organization to prepare for the commercial launch of rese-cel in dermatomyositis. This role involves developing commercial strategies, building high-performing teams, and ensuring operational readiness across all functional areas.

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Director, Validation

Cabaletta Bio Inc. · Full Time · 12 days ago

Cabaletta Bio Inc.

🌎 United States ⭐ 10+ yrs exp 💼 Others

The Director of Validation leads the strategic development and implementation of laboratory validation programs for equipment and computerized systems to ensure GxP compliance. This role oversees the transition from clinical-stage development to commercial launch, ensuring inspection-readiness for BLA submissions.

product-development operations staffing leadership documentation compliance

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Manager, GLP Compliance

Cabaletta Bio Inc. · Full Time · 16 days ago

Cabaletta Bio Inc.

🌎 United States ⭐ 2-5 yrs exp 💼 Legal

Responsible for maintaining GLP compliance across laboratory operations and developing quality control processes to ensure data integrity. The role involves conducting internal audits, managing controlled documentation, and supporting regulatory inspections.

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Associate Director, Corporate Strategy & Development

Cabaletta Bio Inc. · Full Time · a month ago

Cabaletta Bio Inc.

🌎 United States ⭐ 5-10 yrs exp 💼 Others

The role is responsible for defining and managing the product pipeline and research strategy to address unmet medical needs and market opportunities. It also supports the Chief Business Officer in executing business development transactions, including licensing and research collaborations.

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Manager of Supplier Management

Cabaletta Bio Inc. · Full Time · 2 months ago

Cabaletta Bio Inc.

🌎 United States ⭐ 5-10 yrs exp 💼 Others

Provide operational oversight of key suppliers and CDMOs to ensure the steady supply of products and services for patients. Manage supplier governance, track KPIs, and lead cross-functional teams to resolve operational issues and implement CAPAs.

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Sr. Associate of Logistics / Supply Chain - International (Must live in Germany or Switzerland)

Cabaletta Bio Inc. · Full Time · 2 months ago

Cabaletta Bio Inc.

🌎 Germany, Switzerland ⭐ 5-10 yrs exp 💼 Others

Coordinate end-to-end international shipments of patient materials and ensure strict compliance with trade regulations and chain-of-custody requirements. Manage relationships with logistics providers and CDMOs to support the global vein-to-vein supply chain.

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Manager, Global Supply Planning

Cabaletta Bio Inc. · Full Time · 2 months ago

Cabaletta Bio Inc.

🌎 United States ⭐ 5-10 yrs exp 💼 Others

Manage end-to-end supply planning for cell and gene therapy, including 36-month supply plans and biorepository forecasting. Coordinate with CDMOs and internal stakeholders to optimize supply chain efficiency and support the S&OP cycle.

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Director, Investor Relations & External Communications

Cabaletta Bio Inc. · Full Time · 2 months ago

Cabaletta Bio Inc.

🌎 United States ⭐ 10+ yrs exp 💼 Marketing

Lead the development and execution of the company's investor relations and external communications strategy to shape the corporate narrative. Partner with executive leadership to translate scientific progress and clinical milestones into compelling messaging for the investment community.

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Senior Director, Field Medical Affairs Team Lead

Cabaletta Bio Inc. · Full Time · 3 months ago

Cabaletta Bio Inc.

🌎 United States ⭐ 10+ yrs exp 💼 Healthcare

Lead the strategic development and execution of the field medical organization to support cell therapies for autoimmune diseases. This includes building and mentoring an MSL team, managing KOL relationships, and aligning field insights with broader medical and commercial strategies.

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Clinical Sample Manager

Cabaletta Bio Inc. · Full Time · 3 months ago

Cabaletta Bio Inc.

🌎 United States ⭐ 5-10 yrs exp 💼 Healthcare

Manage day-to-day clinical sample activities, ensuring accurate tracking, handling, and documentation throughout the study lifecycle. Collaborate with clinical teams and external vendors to maintain sample integrity and compliance with regulatory requirements.

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Director, Clinical Scientist

Cabaletta Bio Inc. · Full Time · 3 months ago

Cabaletta Bio Inc.

🌎 United States ⭐ 5-10 yrs exp 💼 Healthcare

The Director, Clinical Scientist will lead the clinical development of CAR-T cell therapy programs by overseeing study design, execution, and data interpretation. They will also manage regulatory documentation and collaborate with cross-functional teams to ensure scientific integrity and program success.

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Director, Pharmacovigilance

Cabaletta Bio Inc. · Full Time · 3 months ago

Cabaletta Bio Inc.

🌎 United States ⭐ 10+ yrs exp 💼 Others

The Director of Pharmacovigilance will lead and execute global safety and pharmacovigilance activities across clinical-stage CAR-T programs. This role involves ensuring high-quality safety data collection, analysis, and reporting while collaborating with cross-functional teams to support clinical development and regulatory submissions.

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Sr. In-House Clinical Research Associate

Cabaletta Bio Inc. · Full Time · 5 months ago

Cabaletta Bio Inc.

🌎 United States ⭐ 2-5 yrs exp 💼 Healthcare

The Senior In-House CRA supports the planning, execution, and oversight of clinical trials, acting as a key operational partner to clinical sites, CROs, and vendors. This role ensures high-quality trial conduct, strong external relationships, and inspection-ready documentation throughout the study lifecycle.

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Vice President, Regulatory Affairs

Cabaletta Bio Inc. · Full Time · 5 months ago

Cabaletta Bio Inc.

🌎 United States ⭐ 5-10 yrs exp 💼 Legal

The Vice President of Regulatory Affairs will lead the global regulatory strategy and execution for an advanced cell therapy product development program, ensuring compliance and guiding interactions with global health authorities like the FDA and EMA. This role involves overseeing the preparation and submission of key regulatory documents such as INDs, CTAs, and BLAs/MAAs, while serving as a primary regulatory advisor to executive leadership.

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Vice President, Biostatistics

Cabaletta Bio Inc. · Full Time · 5 months ago

Cabaletta Bio Inc.

🌎 United States ⭐ 10+ yrs exp 💼 Others

This key enterprise leader is responsible for setting the strategic direction, vision, and executional rigor for the company’s biostatistics and data management capabilities, serving as the principal statistical authority across the organization. Key duties include leading and developing the Biostatistics and Data Management functions, providing expert statistical input into clinical development strategy, and overseeing the development and execution of statistical analysis plans for all clinical studies.

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Sr. Medical Director, Clinical Development

Cabaletta Bio Inc. · Full Time · 5 months ago

Cabaletta Bio Inc.

🌎 United States ⭐ 10+ yrs exp 💼 Healthcare

This physician leader will provide medical oversight and leadership for cell therapy programs in autoimmune diseases, collaborating across clinical operations, regulatory, and manufacturing functions while liaising with investigators and Health Authorities. Key duties include formulating study designs, leading protocol development, ensuring operational efficiency through CRO/vendor management, and participating hands-on in all aspects of clinical study conduct, data review, and reporting.

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Director, Regulatory

Cabaletta Bio Inc. · Full Time · 5 months ago

Cabaletta Bio Inc.

🌎 United States ⭐ 5-10 yrs exp 💼 Legal

This role involves serving as the Regulatory Lead for the pivotal program leading to BLA submission, responsible for developing and executing regulatory strategies to support the development and commercialization of cell therapy products. Key duties include managing all regulatory aspects through pivotal studies, preparing applications, managing health authority meetings, and ensuring compliance across global agencies like the FDA and EMA.

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Associate Director, Medical Affairs (Scientific Communications/Publications)

Cabaletta Bio Inc. · Full Time · 5 months ago

Cabaletta Bio Inc.

🌎 United States ⭐ 2-5 yrs exp 💼 Marketing

This role involves managing the end-to-end process for scientific publication planning, ensuring compliance, and collaborating with cross-functional teams to develop manuscripts, abstracts, and presentations. Responsibilities also include managing external vendor execution, budget oversight, and developing comprehensive scientific engagement and congress plans.

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