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The Associate Director, Biostatistics works directly with the medical project team to provide input into and insure the appropriateness of the statistical analysis methods described in the clinical study protocol. S/he develops statistical analysis plans consistent with the clinical trial primary safety and efficacy end points. The Biostatistician reports to the Director of Biostatistics.
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The accounts payable specialist oversees the company’s accounts payable function.
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The Director, Quality External Quality will be responsible for the strategic direction, quality management, and continuous improvement of cGMP Quality activities/support for our outsourced biologics contract manufacturing operations (CMO). In this role, the incumbent will serve as the accountable quality representative at our partner CMO and will be responsible for all quality assurance and quality control activities, including cross-functional partnerships and collaborations.
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The Senior Veeva Vault EDC Manager primarily supports Clinical Operations & Clinical Data Sciences (CO&CDS). Position is responsible for data foundation activities such as: data linkages and visualization of the Immunomedics (IMMU) clinical data; building a secure formatted data repository and utilizing other digital tools in the operational delivery of clinical study trials. The candidate is expected to have broad business systems knowledge and experience in supporting clinical EDC, clinical data sciences planning, oversight and execution of complex global studies across multiple-phases of clinical trials (I – III). As a Subject Matter Expert (SME) for Clinical Digital Solutions, this role includes three primary accountabilities. First, supporting innovation and continuous improvement of digital solutions across the organization by creating awareness of the usage of digital systems in clinical processes. Second, leveraging clinical digital solutions to achieve higher efficiencies and standards that improve cross-functional team collaboration and coordination of operational approaches for delivering studies. And third, provide oversight or management of interactions with CROs and other digital systems vendors to ensure studies are conducted on time, of good quality and within budget. Works collaboratively with Clinical Digital Solutions and with IT in support of clinical and related enterprise digital solutions.
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The Senior Project Manager, EDC, primarily supports Clinical Operations & Clinical Data Sciences (CO&CDS). Position is responsible for data foundation activities such as: data linkages and visualization of the Immunomedics (IMMU) clinical data; building a secure formatted data repository and utilizing other digital tools in the operational delivery of clinical study trials. The candidate is expected to have broad business systems knowledge and experience in supporting clinical EDC, clinical data sciences planning, oversight and execution of complex global studies across multiple-phases of clinical trials (I – III). As a Subject Matter Expert (SME) for Clinical Digital Solutions, this role includes three primary accountabilities. First, supporting innovation and continuous improvement of digital solutions across the organization by creating awareness of the usage of digital systems in clinical processes. Second, leveraging clinical digital solutions to achieve higher efficiencies and standards that improve cross-functional team collaboration and coordination of operational approaches for delivering studies. And third, provide oversight or management of interactions with CROs and other digital systems vendors to ensure studies are conducted on time, of good quality and within budget. Works collaboratively with Clinical Digital Solutions and with IT in support of clinical and related enterprise digital solutions.
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Director, Project Management Office will work as a lead for critical Manufacturing and Quality projects.
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We currently seek motivated professionals who share our passion for science and our dedication to improving the lives of cancer patients. The Oncology Sales Specialist, is a key position within the Immunomedics commercial team. The position will report to the Regional Business Director.
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We currently seek motivated professionals who share our passion for science and our dedication to improving the lives of cancer patients. The Oncology Sales Specialist, is a key position within the Immunomedics commercial team. The position will report to the Regional Business Director.
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The Regional Director, Medical Science Liaisons, will manage and provide leadership to a team of regional Medical Science Liaisons (MSLs) at Immunomedics. The primary responsibilities of this position are to help provide structure and guidance to the company’s field MSL team, and subsequently assist in the hiring and day to day oversight of MSLs within the respective regions. The Regional Director, Medical Science Liaisons will also be responsible for representing the Field Medical Affairs team, both internally and externally, as a clinical expert supporting potential product launches and ongoing pipeline development. This individual will report to the Senior Director, Medical Science Liaisons
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The Regional Director, Medical Science Liaisons, will manage and provide leadership to a team of regional Medical Science Liaisons (MSLs) at Immunomedics. The primary responsibilities of this position are to help provide structure and guidance to the company’s field MSL team, and subsequently assist in the hiring and day to day oversight of MSLs within the respective regions. The Regional Director, Medical Science Liaisons will also be responsible for representing the Field Medical Affairs team, both internally and externally, as a clinical expert supporting potential product launches and ongoing pipeline development. This individual will report to the Senior Director, Medical Science Liaisons
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Provide Quality assistance and oversight during manufacturing of in-process, upstream and downstream, as required. Perform Product Disposition, encompassing the review of production batch records and associated documentation required to release a production lot, as required. This individual manages the batch documentation package and maintains records. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.
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The Director, MSAT will be the technical and leadership resource for the MSAT department, purposed to provide engineering and scientific expertise to tech transfer, process scale-up, equipment and process optimization, technical document authoring, continuous improvement, equipment and process quality system ownership, and on-the-floor mentorship for all large-scale processing.
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The Quality Control Senior Analyst performs product release and stability testing using gel based and capillary electrophoresis methods, reports test results, and performs activities to support equipment qualification and preventative maintenance. General laboratory maintenance as assigned by management.
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We currently seek motivated professionals who share our passion for science and our dedication to improving the lives of cancer patients. The Oncology Sales Specialist, is a key position within the Immunomedics commercial team. The position will report to the Regional Business Director.
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TheBiostatistician works directly with the medical project team to provide input into and insure the appropriateness of the statistical analysis methods described in the clinical study protocol. S/he develops statistical analysis plans consistent with the clinical trial primary safety and efficacy end points. The Biostatistician reports to the Director of Biostatistics.
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Provide Quality assistance and oversight during manufacturing of in-process, upstream and downstream, as required. Perform Product Disposition, encompassing the review of production batch records and associated documentation required to release a production lot, as required. This individual manages the batch documentation package and maintains records. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.
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We currently seek motivated professionals who share our passion for science and our dedication to improving the lives of cancer patients. The Oncology Sales Specialist, is a key position within the Immunomedics commercial team. The position will report to the Regional Business Director.
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Associate Director, Project Management Office will work as a lead for critical Manufacturing and Quality projects.
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The QA Ops Manager manages the Immunomedics Product Disposition Team. Continually evaluates disposition priorities and recommends system improvements. This position also includes direct responsibility for Product Disposition, encompassing the review of Production Batch Records and associated documentation required to release a Production lot. This individual manages the Batch Documentation package, conducting follow-up/ investigations when required and maintaining records in QA. This individual also participates in audits, investigations, SOP preparation, CAPA’s and other projects as appropriate.
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The Quality Management System Specialist executes daily activities and maintains focus on the Change Control, CAPA and Risk Management systems. This position ensures compliance with established and approved quality systems.