Remote

POSITION SUMMARY

• Oversee the design and maintenance of case report forms (CRFs) and electronic data capture (EDC) systems, ensuring accurate and reliable data collection from clinical trial sites.
• Knowledge of broad drug development process with expertise in the data management function.
• Lead the preparation, compilation and filing of all clinical trial documentation related to data management.
• Collaborate with clinical development, medical affairs, and other internal teams to meet operational objectives.
• Manage CROs and vendors that provide data management services.

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

• Oversee or lead study start-up tasks including CRF design, edit check creation, CRF completion guideline (CCG) creation, user acceptance testing (UAT), and data management plan (DMP) development.
• Lead data validation tasks for clinical studies, focusing on data integrity and quality metrics.
• Ensure quality and compliance activities including medical coding, report generation, drug supply, and database integrations.
• Monitor activities and study status for successful deliverables according to the study timeline.
• Proactively review and identify potential issues or problems and escalate to clinical leadership.
• Collaborate with Biostatistics and other colleagues in Clinical Development in preparation for database lock.
• Communicate with staff at clinical site staff, CRO and vendors.
• Oversee efforts of CRO and internal data management personnel to review data entry, raise queries, and perform other tasks as needed to ensure accuracy of study data.
• Ensure accuracy and completeness of clinical trial documentation related to data management.
• Ensure compliance with FDA, GCP, and ICH regulations.
• Other tasks may be assigned at the discretion of the Supervisor.

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

Remote

POSITION SUMMARY

• Provide statistical expertise to support clinical research and drug product
• Collaborate with clinical development, medical affairs, and other internal teams.
• Manage vendors that provide statistical services.

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

• Collaborate with Clinical Development and Medical Affairs on pre- and post-marketing clinical studies.
• Provide statistical expertise for design, analysis, and reporting of clinical trials.
• Implement sound statistical methodology in scientific investigations.
• Oversee development of statistical analysis plans and reporting specifications for clinical studies.
• Contribute statistical expertise to clinical study protocols, study reports, presentation of results, and publication of scientific research.
• Manage vendor statistical services, including design and programming of study data sets and TLFs.
• Partner with Data Management in preparation for database lock.
• Provide statistical support for submission of marketing applications (NDA/BLA/MMA) to FDA, EMEA or other worldwide regulatory agencies.
• Provide statistical oversight of ad hoc data
• Responsible for adherence to biostatistical standards found within all regulatory guidance documents such as ICH and GCP.

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

Remote

This is a junior position that will be mentored directly by the Head of Translational Research at Delcath. The biomarker leader is responsible for the development and implementation of biomarker strategies in clinical trials and drug development programs, including defining scientific objectives, managing biomarker studies, analyzing data, and communicating research findings to company leadership. Working closely with clinical development scientists, the biomarker leader defines the strategy and plans and coordinates operational activities for translational research in multiple clinical studies across all phases. The biomarker leader is accountable for delivering translational research insights on time and within budget.

This position is remote but must be based on the East Coast to allow for time zone efficiencies.

PRIMARY DUTIES AND RESPONSIBILITIES: 

• All aspects related to developing the scientific strategy for translational research in preclinical studies and translational medicine in clinical trials.

• All aspects related to the development, preparation, and update of study and program-related documents, including incorporating biomarker endpoints into clinical protocols, ICFs, biosample management plan, laboratory manuals.

• All aspects related to experiment design and data analysis, data interpretation, scientific report generation and internal & external presentations.

DESIRED KNOWLEDGE & SKILLS:

• Strong scientific background in oncology, and the ability to integrate information from multiple sources to develop testable hypothesis that can advance clinical programs.
• Strong Analytical skills and proven record through publications that the candidate can work independently, through appropriate mentoring, to solve biological problems related to the cancer field.
• Strong verbal, written, and presentation skills. Proven ability to successfully plan, organize, and proactively manage multiple projects and effectively prioritize.
• Ability to work effectively across functions in a matrixed environment and effectively interact with a wide variety of internal and external stakeholders at all levels of the organization.
• Attention to detail and the ability to work in a fast-paced environment.
• Experience in bioinformatics is a plus

EDUCATION AND/OR EXPERIENCE:

• PhD or related degree relevant to oncology (biology, chemistry, medicine).
• MS in related discipline and a minimum of 2 years of relevant experience
• BS/BA degree in a related discipline and a minimum of 4 years of relevant experience

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

Remote

We are seeking a strategic and detail-oriented Product Manager to support the commercial success and lifecycle management of Hepzato Kit. This individual will play a central role in cross-functional project management, product strategy development, and marketing execution. As the key marketing representative on cross-functional teams, the Product Manager will drive product-related initiatives to support market adoption, improve customer experience, and achieve revenue growth targets.

PRIMARY DUTIES AND RESPONSIBILITIES: 

• Collaborate with managers to develop, refine, and execute comprehensive product strategies that align with corporate objectives.
• Monitor market dynamics, competitive activity, and customer insights to guide short- and long-term strategic planning. Support brand positioning, messaging, and go-to-market strategies to maximize awareness and growth.
• Oversee the lifecycle of the Hepzato Kit, including product enhancements.
• Manage day-to-day commercial planning activities including sales enablement tools, product training, and promotional materials.
• Monitor and analyze product performance and forecasting.
• Use data and analytics to drive product decisions and prioritize initiatives.
• Serve as the marketing lead on cross-functional project teams, including Clinical, Regulatory, Quality, Manufacturing, and Sales.
• Coordinate product updates and other initiatives in collaboration with internal stakeholders. Lead and manage timelines for product launches and commercial readiness across functions.
• Support internal needs for primary and secondary market research.
• Engage directly with healthcare providers, KOLs, and strategic partners to gather feedback, assess unmet needs, and collaborate on solutions.
• Develop customer-facing materials and contribute to professional education initiatives. Represent the company at key industry events, conferences, and customer meetings.
• Collaborate with supply chain and operations teams to manage forecasting, inventory planning, backorder mitigation, and quality resolution.
• Track and report on key KPIs and marketing performance metrics; identify opportunities for optimization.
• Partner closely with the sales team to support tactical execution of product strategy and deliver field support tools.
• Assist in the development and execution of marketing campaigns, sales presentations, and competitive positioning resources.

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

Remote

We are seeking a strategic and detail-oriented Commercial Coordinator to assist proposals and marketing content, collaborates with teams, and supports projects and administrative tasks within the Commercial Management team.

PRIMARY DUTIES AND RESPONSIBILITIES: 

• Provide high-level administrative assistance to commercial leadership and teams, including complex scheduling (meetings, procedures, and travel), agenda preparation, documentation tracking, and expense management.
• Serve as a liaison across Commercial, Sales, Marketing, Medical Affairs, and Finance departments to ensure seamless execution of initiatives, clear communication, and timely completion of shared deliverables.
• Continuously evaluate internal workflows, propose solutions to streamline operations, and implement process improvements that drive efficiency, accuracy, and scalability.
• Coordinate and consolidate commercial data from field teams, CRM systems, and internal stakeholders to support business analytics, dashboards, and performance presentations for leadership.
• Collaborate with Sales Managers and the REMS Coordinator to gather, verify, and submit all procedure-related forms prior to patient treatment. Support HCP credentialing processes by communicating directly with physician offices and practice staff.
• Facilitate timely processing of vendor invoices, purchase orders, and consignment agreements, working closely with Sales, Finance, and Procurement to ensure compliance with contractual terms and budget alignment.
• Assist in organizing national and regional events, tradeshows, and advisory boards, including venue coordination, logistics, promotional materials, and post-event follow-up.
• Manage the trafficking of promotional and medical materials through the MLR review process using Pepperflow, ensuring timely submissions, routing accuracy, version control, and follow-up on required revisions or approvals.
• Ensure all materials—such as PowerPoints, one-pagers, internal memos, and trade assets—adhere to company branding and formatting guidelines to maintain a professional, cohesive appearance.
• Contribute to market research efforts, including tracking competitor activity, updating competitive landscape reports, and organizing insights for sales and marketing strategy alignment.
• Manage multiple concurrent projects using project management tools (e.g., Asana, Smartsheet, Monday.com) to track deadlines, assign tasks, and monitor progress.
• Maintain organized libraries of sales, marketing, and training materials to ensure easy access and version control for the field and internal teams.
• Respond to ad hoc requests from field representatives for materials, data, or support with logistics, technology tools, or customer communications.
• Enter, validate, and extract data from CRM systems (e.g., HubSpot, Salesforce) to support campaign tracking, lead follow-up, and territory performance metrics.
• Support the planning, logistics, and execution of advisory boards, including scheduling, contracting, material preparation, compliance documentation, and post-meeting follow-up.

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

Remote

POSITION SUMMARY

• Manage multiple clinical programs to support Health Authority registrations such as INDs, NDAs, MAAs.
• Interact with Delcath teams to ensure consistent performance and superior quality of work.
• Work cross functionally and with CROs and vendors to execute clinical study plans.
• Assess metrics and ensure implementation to support project or program targets and deliverables.

PRIMARY DUTIES AND RESPONSIBILITIES: include the following. Other duties may be assigned.

• Accountable for the management of global clinical studies to ensure ICH-GCP compliance and best practices.
• Ensure timely availability of reports and activities needed to track trial performance.
• Produce trial metrics and manage performance of internal teams and vendors.
• Responsible for the quality of the CRO and vendor work product and deliverables.
• Identify and mitigate issues associated with clinical trials and escalate as needed.
• Provide liaison interface with other line functions.
• Support the development of protocols and study related documents.
• Support in preparing training materials and presentations related to the planning and conduct of the trial.
• Accountable for accuracy of trial information in trial databases and tracking systems.
• Support in the building of trial related systems such as EDC and IRT with the cross functional team.
• Oversee the coordination of drug and device clinical trial supplies.
• Support in the development of trial budget and project timelines.
• Accountable for the Trial master file for studies assigned.
• Responsible for coordinating contract and budget negotiations with clinical sites and vendors.

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

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.

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.

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.