Join Our Crew

Responsibilities Include

Clinical Operations:

• In collaboration with colleagues located globally, develop and execute the clinical operations strategy for Europe and key markets in alignment with company goals and regulatory requirements.
• Build, lead and develop a high-performing clinical operations team in key markets, providing guidance, support and professional development. Mentor and develop staff to foster a culture of collaboration, innovation, and excellence.
• Oversee the planning, design and implementation of clinical trials across Europe and key markets, inclusive of site selection, PI engagement and patient awareness.
• Identify, secure and manage relationships with CROs, vendors and clinical sites to ensure effective collaboration and timely delivery of milestones.
• Report to the VP Clinical Operations and collaborate with Clinical Operations and Finance teams for the overall financial management of assigned studies supporting the development of clinical study budgets, procurement of outsourced services, and forecasting and tracking of actual vs. planned expenses. 
• Ensure compliance with ex-US regulations, including but not limited to ICH-GHP guidelines, EU regulations and local laws governing clinical research.
• Identify potential risks and develop mitigation strategies to minimize impact on clinical trial timelines and objectives.
• Collaborate closely with cross-functional teams including Research, Clinical Development, Regulatory, Quality and Compliance and Medical Affairs to drive integrated clinical development plans.
• Oversee data collection, monitoring and analysis activities to enhance the efficiency and effectiveness of clinical operations processes.
• Prepare for and support regulatory inspections and audits across global regions.

General management:

• Collaborate closely with cross-functional team including Research, Clinical Development, Regulatory, Quality and Compliance and Medical Affairs to drive integrated clinical development plans.
• Live the Cabaletta Values and be an example for the team
• Contribute cross-functional leadership to the development of a best-in-class organization and culture across International operations consistent with Cabaletta Vision and Values.
• Provide regular updates to senior management on the progress of clinical programs, including milestones, challenges and opportunities.

Required Qualifications

Qualifications:

• Advanced degree in life sciences or a related field; (master’s or PhD) preferred.
• Minimum 10 years of experience in clinical operations within the biotech or pharmaceutical industry with cell therapy experience preferred.
• Minimum 5 years’ experience in clinical development with a focus on complex therapies
• Proven track record of successfully managing clinical trials from Phase I through III
• Good understanding of regulatory requirements and registrational pathways
• Good understanding of the EU-specific requirements and opportunities of Cell and Gene products
• Strong understanding of regulatory requirements and guidelines governing clinical research in Europe (EMA, MHRA, etc), 
• International clinical trial leadership experience beyond Europe a plus.
• Excellent leadership and team management skills, with the ability to inspire and motivate cross-functional teams.
• Exceptional communication, negotiation and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.
• Strategic thinker with a results-oriented mindset and demonstrated ability to drive innovation and continuous improvement.
• Strong team orientation and passion for continuous self and team development
• Ability to thrive in a fast-paced, dynamic startup environment and adapt to evolving priorities and challenges.

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