Sr. Manager/Associate Director, Supply Chain Operations – International

Key Responsibilities

Supply Chain Setup

• Support the selection, onboarding, qualification and contracting of Clinical Treatment Centers outside the US.
• Provide expertise on both the physical and financial flows of materials across the supply chain.
• Support Cabaletta stakeholders in establishing ex-US operations, translating preferred financial flows into operational processes, and managing import/export activities.
• Develop, implement, and maintain trade compliance policies and procedures aligned with evolving regulatory requirements.
• Design and manage a robust framework to support cross-border clinical and future commercial activities outside the US.
• Oversee accurate product classification, country of origin determination, selection of preferred incoterms, and ensure compliance with VAT and tax regulations in collaboration with the International Finance team.
• Establish, roll out and embed processes and tools to enable effective and smooth operations between Cabaletta, its Partners and the Treatment Centers, as well as internal operations, driving continuous enhancements.
• Collaborate with cross-functional teams to develop, roll out, maintain and enhance critical business systems and tools (e.g., ERP, traceability tools).

Supply Chain Operations

• Act as Cabaletta’s subject expert matter on the “vein-to-vein” supply chain for ex-US patients.
• Collaborate with 3rd party providers: customs broker, courier, IOR/EOR representative, cryopreservation sites, CDMO’s, clinical sites) to streamline drug product delivery to patients.
• Partner with the internal Treatment Center Readiness team to ensure a smooth start of clinical operations.
• Align cross-functional teams (internal and external) through timely and effective communication.
• Lead and manage trade compliance programs, ensuring adherence to international trade regulations.
• Facilitate and lead cross-border trade operations, ensuring efficient product movement across Cabaletta’s supply chain.
• Conduct thorough reviews of shipping and customs documentation, both pre- and post-shipment, to ensure accuracy and compliance.
• Act as the Finance – Supply Chain liaison, integrating the ex-US demand forecast into the Global demand planning to optimize the patients’ treatment planning.

Supply Chain Strategy

• Support the ex-US CDMO future strategy.
• Contribute to the short, mid and long-term strategy enabling Cabaletta to scale manufacturing across clinical phases (I,II,III) and commercialize products.
• Identify and support the next wave of supply chain innovations in CAR-T.
• Monitoring our key competitors supply chain operations ex-US.

Qualification & Requirements

• Bachelor’s degree or the combination of education and business experience required.
• 6+ years relevant experience (e.g. Supply Chain or Trade Compliance) in the biotech and/or pharmaceutical industry required, ideally in cell and gene therapy.
• Experience managing a Trade Compliance function in Europe and International.
• Experience transitioning from clinical development to commercial environment is desirable.
• Excellent communication and presentation skills are necessary.
• Experience managing cross functional initiatives and building and implementing processes.
• Experience with clinical operations.
• Approximately 25% travel may be required.
• Highly self-motivated individual, with demonstrated ability to work independently in a fast-paced and complex environment.

Benefits

Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.