Europe

POSITION SUMMARY

We are seeking a motivated and collaborative Medic – EU to join our growing clinical development team. This full-time role will support global clinical trials across multiple programs, working closely with cross-functional teams, investigators, CROs, and study sites. The ideal candidate is a physician (MD or equivalent) with clinical research experience who thrives in a fast-paced, hands-on environment and is passionate about advancing new therapies.

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

Strategic Objectives

• Support the execution of the global clinical development strategy with high-quality trial conduct.
• Build collaborative relationships with external investigators, CROs, and cross-functional internal teams.
• Provide clinical insights to optimize patient recruitment and retention.
• Contribute to ongoing safety signal detection, risk mitigation, and data integrity oversight.
• Support future protocol amendments, expansion cohorts, and potential new development programs.

Operational Objectives

• • Ensure protocol compliance and patient safety through active medical monitoring.
  • Serve as a first-line medical resource for investigators and site queries.
  • Collaborate with clinical operations to monitor enrollment progress, resolve operational issues, and ensure trial timelines are met.
  • Support training of site personnel and CRO staff on protocol requirements and safety procedures.
  • Contribute to clinical trial quality assurance, data review, and inspection readiness efforts.
  • Attendance at scientific and medical conferences.
  • Assist with analytical support of clinical trial data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.

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

Queensbury, NY

POSITION SUMMARY

The Quality Assurance Technician position is responsible for performing duties that help to organize and maintain an effective quality system.  The overall purpose of the position is to support the company goal of ensuring that Delcath is fully compliant to all applicable FDA and ISO regulations.

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

• Responsible for monitoring and confirming manufacturing process activities
• Review/issue DHR’s to support Manufacturing operations
• Perform/review line clearance activities to support Manufacturing operations
• Responsible for reviewing manufacturing records and verifying data
• Perform in-process inspection of medical devices and device components
• Perform final product inspection and final release activity
• Responsible for organizing and performing Incoming Inspection duties
• Responsible for performing environmental monitoring testing, organizing data and creating reports
• Implement supplier corrective actions and non-conforming product reports
• Assists and performs quality investigations with supervision
• Manages CAPAs with supervision
• Support in verification/validation testing
• Internal audits
• Other duties as assigned

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

Queensbury, NY

POSITION SUMMARY

The Chemist will play a critical role in product release testing and will participate in QC/ R&D activities related to product development.

The incumbent must demonstrate a high level of involvement in continuous improvement activities to ensure the highest standards are maintained.  The Chemist must possess the ability to solve practical problems and deal with a variety of situations in a fast-paced environment.

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

• Assist with the end-to-end process of batch release testing which includes but not limited to preparation of drug solution, sample collection, data review/ analysis, and other.
• Proactively take measures to ensure that all equipment is current with calibration and PM services, where applicable.
• Comply with GDPs for maintenance of data and records. Maintain knowledge of organizational SOPs and apply where needed.
• Participate in developing and validating QC test methods while complying with Quality Management Systems (QMS), in accordance with ISO standards and regulatory requirements.
• Responsible for R&D activities including writing/ executing protocols, preparing standards/ reagents/ solutions, analysis of samples using LC-MS on a routine basis.
• Responsible for maintaining the LC-MS instrument per set requirements.
• Assist with effective planning and organizing of R&D lab activities to meet set project deliverables. Collaborate with peers/ external teams to organize and conduct research.
• Comprehend, and effectively communicate technical data across cross-functional teams.

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

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

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.