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Responsible for leading the Drug Product development and validation of all commercial and clinical products under cGLP and cGMP guidelines.
Medical Science Liaison (MSL) is a field-based representative of the Medical and Scientific Affairs Organization. The MSL is responsible for being a liaison to the medical and scientific community on behalf of Immunomedics. This includes identification and relationship building of Key Opinion Leaders (KOLs) and providing for meaningful scientific exchanges at national, regional and local levels in both academic and clinical practice settings. The MSL plays a critical role in introducing and managing Client’s presence in the oncology (breast cancer) space in the US initially in a prelaunch setting.
The Senior IT Business Analyst is responsible for business analysis within the Operations business technology area, supporting global Supply Chain, Manufacturing, Quality, and other Operations support functions. The position is responsible for overseeing activities for gathering, analyzing and prioritizing functional and non-functional requirements to facilitate the development of systems or technical solutions for complex business issues. This includes development of comprehensive domain business process models used to guide continuous improvement initiatives and overall understanding of the business processes key to Operations. 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 IT Business Analyst Operations and Quality 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.
The Senior Clinical Study Manager will be accountable for the overall management of assigned clinical studies and oversight of assigned clinical vendors.
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.
We are seeking a Senior Statistical Programmer to provide statistical programming and analytic support clinical studies.
- This position will require hand-on Clinical Data Management activities
- To provide CDM subject matter expertise to the study team(s) and is responsible for overseeing and managing all CDM activities for the study.
- Serves as a core team member of the Study Team(s) and is accountable for all CDM-related communications, specifications, and documentation that includes but not limited to the Data Management Plan (DMP).
- The Data Management Project Leader (DMPL) is responsible for the overall quality and integrity of the clinical database, and they work collaboratively to ensure that Immunomedics’ Clinical Data is collected, managed, and reported clearly, accurately, and securely based on the study’s protocol and to the highest scientific industry standards
The Associate Director (AD), Clinical Operations is responsible for the strategic planning, oversight and execution of Ph1/II/III studies across indications or programs. The AD of Clinical Operations will have program oversight responsibilities while also managing a study or studies. Responsibilities include, but are not limited to, establishing program study timelines and budgets, overseeing the day-to-day operations of clinical trials from study design through close-out, ensuring studies are conducted in accordance with appropriate regulatory requirements and within established timelines and budget, leading cross-functional teams and managing relationships with investigator sites, vendors and consultants. The AD of Clinical Operations is also responsible for leading or contributing to company process improvement initiatives.