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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 position is responsible for building relationships, account plans and executing strategies to improve patient access and drive company performance within key National Accounts (Payers, IDNs, large organized customers).
The position is responsible for leading the matrix team in account planning and implementation, driving optimal access, and appropriate utilization of launch product in all assigned accounts. These include national payers, the largest oncology networks, pathway companies, and other oncology organized customers. Deep knowledge and understanding of the clinical, economic and business model dynamics driving decision making and coverage is critical. Deep understanding of the business of oncology and the clinical label and data for launch product and competition are essential.
The National Account Director is responsible for developing strong access and business relationships and communicating approved clinical and economic data with key oncology decision makers and advisors within a variety of key accounts. Knowledge and understanding of oncology access influencers is also important. This includes groups like ASCO, ACCC, COA, NCCN, State Oncology Societies, etc. The National Account Director develops and ensures execution of the account business plans which include both strategic and financial objectives. The National Account Director is responsible for aligning the full matrix team to execute the plan. The position serves as the primary interface between Immunomedics and our national oncology customers. The position reports directly to the Director, Payers and Strategic Accounts.
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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 position is responsible for building relationships, account plans and executing strategies to improve patient access and drive company performance within key National Accounts (Payers, IDNs, large organized customers).
The position is responsible for leading the matrix team in account planning and implementation, driving optimal access, and appropriate utilization of launch product in all assigned accounts. These include national payers, the largest oncology networks, pathway companies, and other oncology organized customers. Deep knowledge and understanding of the clinical, economic and business model dynamics driving decision making and coverage is critical. Deep understanding of the business of oncology and the clinical label and data for launch product and competition are essential.
The National Account Director is responsible for developing strong access and business relationships and communicating approved clinical and economic data with key oncology decision makers and advisors within a variety of key accounts. Knowledge and understanding of oncology access influencers is also important. This includes groups like ASCO, ACCC, COA, NCCN, State Oncology Societies, etc. The National Account Director develops and ensures execution of the account business plans which include both strategic and financial objectives. The National Account Director is responsible for aligning the full matrix team to execute the plan. The position serves as the primary interface between Immunomedics and our national oncology customers. The position reports directly to the Director, Payers and Strategic Accounts.
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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 Director, Biostatistics works directly with the medical project team to provide input into and ensures 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 Sr. Director of Biostatistics.
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This Quality Control Associate Director, Reference Standards / QC Metrology is a subject matter expert on both the QC Reference Standard Program and QC Metrology Program functions within a cGMP QC laboratory.
Reference Standard Program:
This position requires prior experience in product characterization assays and management of in-house primary and working reference standards procedures. Through coordination of in-house and contract laboratories, this position will coordinate the sourcing, testing and release of product reference standards for antibody drug conjugate products, product intermediates, provides technical input to management. He /She will also manage the inventory of reference standards, support the Stability Program, ensuring continuity of supply across a global network of in-house and contract testing laboratories. Responsibilities include authoring of testing protocols, test plans, review of batch records, release of test results and maintenance inventory control as described below.
QC Metrology Program:
This position requires prior experience with QC metrology and QC equipment qualification procedures. Through coordination of in-house metrology and contract vendors, this position will coordinate activities associated with the maintenance, calibration and qualification of all equipment/instrumentation utilized within the QC laboratory for antibody drug conjugate products, product intermediates. He /She will also manage vendor service contracts for all QC equipment/instrumentation ensuring the availability for all QC testing requirements. Responsibilities also include the authoring of IQOQPQ documentation for all QC equipment/instrumentation.
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The Project Manager works cross-functionally and collaboratively to support product development and life cycle management activities. This position will ensure consistent and effective project management leadership of global drug development project teams.
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Reporting to the Vice President, External Manufacturing, develop and Implement the lifecycle of contract manufacturing strategy for commercial or clinical products at one or more monoclonal antibody third party manufacturing organizations (CMO). Activities include CMO selection, process technology transfer, CMO management, and routine cGMP manufacturing monitoring and management. Establish and maintain alignment between CMO site business, operations and quality objectives and plans and Immunomedics commercial/clinical manufacturing strategies and plans. Establish and manage business operations, and quality relationships and communications between Immunomedics and the CMO as the lead point of contact for Immunomedics. Build and lead cross functional teams of technical, quality, regulatory, manufacturing, engineering, supply chain and other subject matter experts to achieve CMO site business, operations and quality objectives, plans and performance goals. Provide the single point of accountability for identifying and managing timely resolutions of business, operational and quality issues through established CMO site governance structure. Provide strategy planning for scaleup and second source activities across the whole global supply chain. Build and Manage team of Persons in Plant to cover global supply chain.
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Responsible for leading the purification process development and validation of all commercial and clinical products under cGLP and cGMP guidelines.
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Reporting to the Sr. Director GxP Quality & Compliance, the Associate Director, GxP Quality Compliance will play a critical role in helping define the development, implementation, maintenance and continuous improvement of global Compliance programs to support Global GxP operations and supply within Immunomedics and ensure compliance with relevant regulations.
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Reporting to the Sr. Manager, IT Quality Compliance, the Sr. IT Quality Compliance Specialist will play an important role in the daily IT QA oversight, review and approval of IT related deliverables for laboratory, manufacturing, and warehouse systems. This position ensures compliance with established and approved IT and GxP procedures, guidance and regulations.
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The Director, Patient Experience will be responsible for developing and implementing the patient advocacy function in accordance with patient experience strategic priorities.
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The Associate Director, Clinical Operations will be responsible for the execution of the Clinical Operations strategy and overall delivery of clinical trial(s). This position will be responsible for clinical operations planning, oversight and execution of global studies within the development program. As a clinical operation expert, this role includes three primary accountabilities. First, development and coordination of operational approaches and delivery. Second, cross-functional team leadership for critical global studies. And third, oversight of and interactions with CROs and other external vendors to ensure studies are conducted according to timelines, budget and quality plans.
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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 Business Analyst is a key contributor to the success of the Clinical, Regulatory and Safety functions. The position is responsible for overseeing and executing activities for gathering, analyzing and prioritizing functional and non-functional requirements to facilitate the development of systems or technical solutions for complex business needs. This includes development of comprehensive domain business process models used to guide continuous improvement initiatives and overall understanding of key business processes. The Senior Business Analyst works closely with key business stakeholders, SME’s, IT peers, validation and other team members to identify and document business requirements needed to identify possible solutions for data, processes, interfaces, controls, systems, outputs, etc.
The Senior Business Analyst will work in partnership with other domain business analysts in the development of best practices, standardized templates and business analyst methodologies to be practiced across the organization.
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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.