Medical Director/Senior Director, Clinical Development

Valid8 Financial, Inc.; Philadelphia (Philadelphia County); Remote; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Sr. Manager/Associate Director for Supply Chain Operations to optimize international supply chains. This role involves overseeing the selection of Clinical Treatment Centers, developing trade compliance policies, and collaborating with cross-functional teams to enhance operational efficiency. You will act as a subject matter expert on the CAR-T supply chain for ex-US patients, ensuring seamless drug delivery and compliance. If you are passionate about improving patient outcomes through innovative supply chain solutions, this opportunity could be your next career step.

Qualifications

• 6+ years of experience in Supply Chain or Trade Compliance in biotech/pharma.
• Experience managing trade compliance in Europe and internationally.

Responsibilities

• Oversee international supply chain operations and compliance.
• Support selection and management of Clinical Treatment Centers.

Skills

Supply Chain Management

Trade Compliance

Cross-functional Collaboration

Communication Skills

Clinical Operations

Education

Bachelor's Degree

Tools

ERP Systems

Traceability Tools

Job description

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA.

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.

About the Position:

We are looking for a Sr. Manager/Associate Director, Supply Chain Operations – International to join our team, reporting directly to the Vice President, Supply Chain Operations. You will oversee and optimize our international supply chain operations, ensuring seamless integration and compliance. Your role will involve supporting the selection and management of Clinical Treatment Centers, developing trade compliance policies, and collaborating with cross-functional teams to enhance business systems.

As the subject matter expert on the CAR-T "vein-to-vein" supply chain for ex-US patients, you will work with third-party providers to streamline drug product delivery and support clinical operations. Your strategic insights will help shape our supply chain innovations and enable Cabaletta to scale manufacturing from early to late clinical development until commercialization.

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.

Qualifications:

• 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.

Location: This position is based in Switzerland (potentially Germany), fully remote work with travel estimated up to 25%.

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.