PEOPLE + CULTUREAt Delcath, every day begins with a profound opportunity to impact lives across the globe.

Here, your passion, whether it’s rooted in science, creativity, or digital expertise, becomes part of a larger mission to tackle some of the most significant medical challenges. Our collaborative environment is fueled by a collective drive to innovate and bring hope to individuals facing serious health conditions. As we continue to grow and evolve, we seek intellectually curious individuals eager to contribute their unique talents and make a significant mark. Come be a part of our dynamic team and start making a difference from day one.

OUR COMMITMENT TO PATIENTSWe are committed to providing safer, more effective, and minimally invasive therapies tailored to the unique needs of our patients.

Through our pioneering technology and innovative procedures, we strive to improve not just clinical outcomes but also the quality of life for those we serve. Our promise is to uphold the highest standards of care, ensuring each patient receives personalized treatment with the utmost compassion and respect. Together, we are setting new benchmarks in interventional oncology, fostering a future where liver cancer treatment is synonymous with precision, safety, and trust.

OUR VALUES

Our mission is to revolutionize the treatment of primary and metastatic cancers through groundbreaking therapies, and we are guided by a core set of values that inspire our work.

Innovation

Revolutionizing systems, shifting the paradigm

Results-oriented

Accountability and meeting commitments

Compliance

Operating within a given set of parameters to ensure quality and safety

Customer-focused

Meeting the needs of patients, physicians, and investors

Teamwork

Cross-functional trust, reliance and collaboration

Market Leadership

Leading with passion and focus, aiming to win

WHAT WE OFFERWe’re excited to provide a complete benefits package, including a comprehensive health plan, 401(k), and professional development opportunities, to support the well-being and growth of our employees and their families.

Employee stock purchase plan + 401k savings

Join our Employee Stock Purchase Plan and 401k to invest in your future with us. Learn more

Health, vision and dental insurance

Enjoy comprehensive health, vision, and dental insurance coverage for you and your family.

Professional development program

Advance your career with our robust professional development program.

Life, disability, and supplemental insurance

Get peace of mind with our life, disability, and supplemental insurance options.

Open Roles

Join our team at Delcath Systems and be part of pioneering the future of cancer treatment innovations.

Clinical Trial Manager

Remote

This position is responsible for overseeing all facets of assigned clinical studies including:

  • Overall management for the planning, execution and reporting of multiple clinical studies/programs (phase I –III)needed to support Health Authority registrations such as INDs, NDAs, MAAs, etc.
  • Interact with Delcath teams to ensure consistent performance and superior quality of work.
  • Ability to work cross functionally and with CROs, as required, to appropriately execute clinical study plans.
  • Assess metrics and ensure implementation of appropriate measures as necessary to support project or programtargets/deliverables.
PRIMARY DUTIES AND RESPONSIBILITIES: include the following. Other duties may be assigned.

Accountable for the management of clinical trials

  • Lead and collaborate on the implementation of clinical development programs.
  • Accountable for the management of global clinical studies to ensure GCP compliance and “best practices”.

      • Ensure timely availability of reports/activities needed to track trial performance.

      • In collaboration with Sr. Management produce trial metrics and manage performance of internal teamsand CRO.

      • Responsible for the quality of the CRO work product and deliverables. Creates vendor oversight plans tooversee and manage CROs and other vendors.

      • Provide liaison interface with other line functions

      • Identifies and reports issues and solutions, escalating as needed.

      • Support the development of protocols and study related documents.

      • Support in preparing training materials and presentations related to the planning and conduct of thetrial.

      • Accountable for accuracy of trial information in all trial databases and tracking systems. Responsible fordata management and the delivery of individual trial data within agreed upon time frame and inaccordance with acceptable ICH quality standards.

      • Oversees the coordination of drug and device clinical trial supplies.

      • Develops and manages trial budget and project timelines

      • Accountable for the Trial master file for studies assigned

      • Responsible to coordinate or lead contract and budget negotiations with clinical sites and vendors.

To apply for this position, please send your resume to jobs@delcath.com.

Clinical Research Associate

Remote

This position is responsible for assisting in the coordination of clinical studies within a Project Team environment and further assisting in the preparation, compilation, distribution and filing of all documentation related to the function of the Project and Study Teams, contributing to the effective communication of all materials related to the operation of the Project and Study Teams and, in general, supporting the Project and Study Teams to ensure that the project goals are met.

PRIMARY DUTIES AND RESPONSIBILITIES:

  • Coordinates Documentation by working with the other members of the Project and Study Teams, assures that all critical documentation pertaining to clinical trials is tracked, distributed, and filed according to Standard Operating Procedures (SOPs) and regulatory guidelines set forth by applicable regulatory agencies; by attending Project and Study Team meetings and managing critical documents such as agendas, presentations, and minutes; by reviewing regulatory documents for Institutional Review Board (IRB)/Ethics Committee (EC) submissions; by supporting and tracking development of budget proposals and invoices for assigned projects, updating system with invoices for approval, reviewing monitoring reports; and by performing other tasks as requested by the Supervisor.
  • Provides Clinical Trial Project Support by serving as a key resource to all members of the Project and Study Teams, both internal and external; by administering and tracking clinical trial enrollment for assigned Studies; by assisting in the preparation and tracking of trial budgets, clinical supplies and laboratory samples; and by performing other tasks as requested by the Supervisor.
  • Supports the development of study related documents and tools as requested by the Supervisor.
  • Performs CRO Coordination by attending regularly scheduled study team meetings; following up on action items, as necessary; by providing feedback, as necessary to CRO staff and other vendors; by tracking and reviewing monitoring reports under guidance of Supervisor and escalates issues, as appropriate; and by performing other tasks as requested by the Supervisor.
  • Complies with Regulations by following all Company procedures to ensure compliance with FDA, GCP, and ICH regulations, federal and state laws, related statutes, and SOPs; and by advising the study team as necessary on matters affecting project success.
  • Other duties may be assigned.

To apply for this position, please send your resume to jobs@delcath.com.

Manufacturing Engineer

Queensbury, NY

The primary responsibilities of a Manufacturing Engineer include:

  • supporting production by performing equipment troubleshooting, PMs on process equipment, and resolving day to day manufacturing concerns as they arise, and
  • supporting the business by developing and implementing process/product improvements, and resolving supplier change notifications.
PRIMARY DUTIES AND RESPONSIBILITIES:

  • Assist Product Development with researching and improving device design and/or quality utilizing new technology, products, materials, and equipment.
  • Develop and implement manufacturing processes improvements, which foster lean manufacturing principles.
  • Innovate and define technical solutions for research/development/design problems and lead efforts to realize the technical solutions.
  • Assist with the research, design, prototype and test new products and processes.
  • Complete complaint investigations and assist with documenting responses to customers
  • Manage and implement supplier change notifications
  • Complete root cause investigations associated with product/process non conformances and implement solid corrective actions to prevent reoccurrence.
  • Lead and/or participate in project design reviews and development of use, design & process FMEA’s
  • Write protocols, implement and lead process validation activities
  • Write test methods and test method validation protocols/reports
  • Perform/oversee test method validations and/or product testing
  • Perform a wide variety of laboratory tasks and experiments to support the Company’s research and development goals such as maintain laboratory equipment and inventory levels for laboratory supplies, test product per protocols and test/inspection procedures
  • Research/recommend, source & purchase Lab Equipment (from calipers to large test equipment (tensile tester, etc.)
  • Perform equipment troubleshooting to maintain the required manufacturing output, as required
  • Perform drafting/designer duties to create and revise fixtures, equipment, component and product drawings
  • Assist other engineers in process development activities to support new product launches
  • Perform PM’s and assist with calibrations on equipment, as required.
  • Other duties may be assigned.

To apply for this position, please send your resume to jobs@delcath.com.

Medical Director

Remote

This position involves medical oversight, medical monitoring and clinical team leadership for one or more clinical studies. Hands-on responsibility for developing clinical study protocols, medical/scientific sections of translational research plans and regulatory documents, participation in internal and external clinical strategy discussions, matrix and/or line management of the clinical team, peer to peer interactions with clinical science, statistics, data management, clinical operations.

PRIMARY DUTIES AND RESPONSIBILITIES:

  • Participate in clinical strategy development. Take the lead in compiling input from subject matter experts (external KOLs, Clinical, Biostatistics, Regulatory, Commercial, Finance) to Clinical Development Strategy to support existing and develop new indications for HEPZATO KIT.
  • Leadership of multidisciplinary clinical study team.
  • Hands on responsibility for medical monitoring, interactions with clinical study participants, implementation of clinical study protocols.
  • Partnering and collaboration with Commercial, Regulatory, Legal and other departments.
  • Partner with US and European colleagues on US, EU and global clinical development and medical affairs projects.
  • Participation in IIT and Translational Research study reviews.
  • Clinical study data review, writing of relevant sections of scientific and regulatory documents.
  • Attendance at scientific and medical conferences.
  •  For assigned studies, act as recognized clinical expert and provide medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/ exclusion determinations, and issues of patient safety and/or eligibility.
  • Assist with analytical support of clinical trial data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
  • Other duties may be assigned.

To apply for this position, please send your resume to jobs@delcath.com.

At Delcath Systems, Inc., we are committed to an inclusive environment where people can thrive. We seek to recruit, develop, and retain the most talented people from a diverse candidate pool. The company is proud to be an equal opportunity employer. We do not discriminate on the basis of race, gender, religion, age, sexual orientation, national origin, disability status, or any other characteristic protected by law. Our focus on diversity and inclusion is grounded in our company’s core values and is essential to our success.