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Responsible for formatting and publishing electronic documents, and building of regulatory submission deliverables ensuring submissions are of highest quality and delivered on-time. The position will also archive and track regulatory correspondences, documents and submissions.
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Associate Director of Quality Systems provides oversight to Quality Systems such as change control process, document control / management, Risk Management and, Computer System Validation (CSV), and general QA Validation oversight. Quality System group will also manage Quality System updates and provide day to day management to these Quality Systems. QA System group will provide trending for Quality Systems. This position may also be cross trained to cover other QA functions as needed.
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The Biostatistician 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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Senior Manager, Regulatory Project Management, under direction of the Director of Regulatory Project Management, will work effectively with product development teams to establish and manage timelines and deliverables in support of global regulatory submissions, with a focus on CMC submissions. This individual will coordinate submissions using Veeva Vault RIM, establish submission timelines and track progress for submission deliverables, coordinate/ support cross-functional submission planning meetings, and collaborate closely with Regulatory Operations for submission execution.
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The Scientist, Upstream Process and Manufacturing Sciences is responsible for the development and operation of mammalian cell culture processes under cGLP conditions.
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Function in the analytical group of Process and Manufacturing Sciences to support process and product development and characterization.
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Responsible for leading the Analytical Methods development and analytical characterization of commercial and clinical products.
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The Maintenance Mechanic will be responsible for helping to maintain the Immunomedics facility and the various equipment and systems that enable us to operate.
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The Engineering Systems Coordinator will be responsible for administering the Engineering and Maintenance compliance systems to include: Work Order generation / planning and delegation, Environmental Monitoring System / Building Monitoring System.
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We are seeking a Principal Statistical Programmer to provide statistical programming and analytic support clinical studies.
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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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Reporting to the Vice President, Global Head of Safety and Pharmacovigilance, the Senior Medical Director will be responsible for the oversight of all medical safety functions for Immunomedics’ products, both those in clinical development and marketed products. This global role involves both strategic and operational aspects. The Senior Medical Director will be responsible for the ongoing safety surveillance of Immunomedics’ products, including evaluation of safety data from all sources, signal detection, benefit-risk evaluation, and, development and implementation of risk management strategies, and will lead cross-functional Safety Management Teams. Additional responsibilities include oversight of medical safety functions performed by vendors, such as medical review of individual case safety reports, and oversight/authoring of safety sections of regulatory submissions, including periodic reports and marketing authorization applications. This role will involve close collaboration with the Clinical Development teams, Regulatory Affairs, Medical Affairs, and Clinical Quality Assurance functions, and the Senior Director, Safety and Pharmacovigilance. The Senior Medical Director will be the Subject Matter Expert for safety and pharmacovigilance issues related to Immunomedics’ products, other related products (both in development and marketed), and the indications under study. Importantly, the Senior Medical Director will aid the Global Head in strategic planning for creating and implementing state-of-the-art processes for safety surveillance, signal detection, benefit-risk evaluations, and risk management activities, and developing an organizational structure to support these activities.
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Director, CMC Regulatory Affairs will translate regulatory requirements working effectively with the respective process and manufacturing teams to collaborate, implement and interact meaningfully into workable strategies and plans for various stages of drug development of drug substance and drug product. This individual develops and implements CMC regulatory strategies to support the conduct of clinical trials and registrations in the US and global markets for the development and commercialization of pipeline drugs in the context of submissions to, and communications with, the Health Authorities while actively contributing as a key member of the project team.
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The purpose of the Senior Manager role is to:
1) Develop category strategies for raw materials, supply chain/logistics and other assigned categories.
2) Plan and execute the sourcing process for all relevant activities.
3) Execute and adhere to Corporate Procurement strategy, policy, systems, and processes.
The Senior Manager, Raw Materials and Supply Chain Sourcing will work within multi-disciplinary team and assume responsibility for leading the development and execution of Raw Materials/Supply Chain sourcing strategies to leverage relationships with suppliers, global affiliates and CMO partners to gain competitive advantage. This includes negotiation, supplier relationship and performance management, and risk management. Strengthens and develops relationships with key partner organizations.
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The purpose of the Senior Manager role is to:
1) Develop category strategies for raw materials, supply chain/logistics and other assigned categories.
2) Plan and execute the sourcing process for all relevant activities.
3) Execute and adhere to Corporate Procurement strategy, policy, systems, and processes.
The Senior Manager, Raw Materials and Supply Chain Sourcing will work within multi-disciplinary team and assume responsibility for leading the development and execution of Raw Materials/Supply Chain sourcing strategies to leverage relationships with suppliers, global affiliates and CMO partners to gain competitive advantage. This includes negotiation, supplier relationship and performance management, and risk management. Strengthens and develops relationships with key partner organizations.
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We are seeking a Senior Statistical Programmer to provide statistical programming and analytic support clinical studies.
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This position requires a sound working knowledge of clinical data management processes and database systems within a multi-disciplinary team environment.
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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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Creates, reviews, and revises technical documentation of procedures and practices associated with the Validation department. Ensures appropriate maintenance of technical documents, provides various support, and coordinates activities for the Validation department.
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The Validation Engineer will be responsible for the completion of assigned validation projects encompassing equipment, instruments, computers, cleaning, and process areas for the entire validation lifecycle.