Click column header to sort
-
Responsible for purification process development and validation of all commercial and clinical products under cGLP and cGMP guidelines.
-
The Senior Clinical CTMS Manager within the Clinical Digital Solutions team is responsible for management, maintenance, and improvement of the Clinical Trial Management Systems involved in the planning, execution, oversight, and closure of clinical trials in accordance with regulations and SOPs. This position primarily supports Clinical Operations in establishing and maintaining oversight of cross-functional trial operations through optimized design and use of the CTMS environment and related system integrations, including eTMF, EDC, and other systems.
-
The Manager/Sr. Manager Clinical Supply QA will work in all phase of clinical development to provide quality oversight for clinical packaging and supply chain activities. Actively contributes and supports QA Leadership in the risk-based Clinical Quality Assurance (CQA) oversight for internal and external GMP process and systems supporting Immunomedics clinical trials. Provides GMP compliance support to Clinical development and operations, including QMS development/maintenance. Provides day to day compliance support to Supply Chain, Clinical study teams and cross-functionally to other functional areas, e.g., Regulatory, medical affairs.
-
The Manager/Sr. Manager Quality Assurance Clinical GMP will work in all phase of clinical development to provide quality oversight for clinical packaging and supply chain activities. Actively contributes and supports QA Leadership in the risk-based Clinical Quality Assurance (CQA) oversight for internal and external GMP process and systems supporting Immunomedics clinical trials. Provides GMP compliance support to Clinical development and operations, including QMS development/maintenance. Provides day to day compliance support to Supply Chain, Clinical study teams and cross-functionally to other functional areas, e.g., Regulatory, medical affairs.
-
Role is responsible for strengthening the risk-based monitoring approach/practices and the applied oversight of our vendors. This highly specialized role, focused on monitoring excellence across the portfolio, will develop solutions to fuel a high-performing practice from study initiation through site closure. With a strong emphasis on inspection readiness and compliance, this leader will drive the relevant risk management framework and contribute to the internal education of personnel on the compliant management of monitoring in clinical trials globally.
The role requires regular contact with persons of influence and in decision-making positions within R&D and with CROs. As such, The Director, Clinical Ops Performance Excellence requires strong oral and written communications expertise, and the ability to influence while obtaining desired outcomes in a goal-oriented environment. Ability to work independently and deliver results throughout the cross-functional network is critically important
-
Role is responsible for strengthening the risk-based monitoring approach/practices and the applied oversight of our vendors. This highly specialized role, focused on monitoring excellence across the portfolio, will develop solutions to fuel a high-performing practice from study initiation through site closure. With a strong emphasis on inspection readiness and compliance, this leader will drive the relevant risk management framework and contribute to the internal education of personnel on the compliant management of monitoring in clinical trials globally.
The role requires regular contact with persons of influence and in decision-making positions within R&D and with CROs. As such, The Director – Clinical Ops Risk Management requires strong oral and written communications expertise, and the ability to influence while obtaining desired outcomes in a goal-oriented environment. Ability to work independently and deliver results throughout the cross-functional network is critically important.
-
Immunomedics is looking for a Vice President of Corporate Affairs. This person is responsible for leading the overall strategic direction and implementation of Immunomedics’ corporate affairs initiatives across multiple channels and audiences, including media, analysts and investors, advocacy partners, and government affairs. Ideally, the candidate has experience in corporate/ government affairs, investor relations, corporate branding, identity and reputation management, general media relations, including traditional and social media strategy, and an understanding of the advocacy landscape within oncology.
The Vice President will also be responsible for planning and implementing an employee communications plan in light of the corporate vision, strategy and goals. The candidate must be an exceptional communicator (written and oral) and influencer with strong business acumen and have demonstrated team building and leadership capabilities and presence.
The Vice President will be a close advisor to senior leaders and partner closely with Commercial, Corporate Operations, Human Resources, and other cross-functional teams to ensure consistent messaging and communications governance, while identifying and executing complementary initiatives.
We are looking for team members who will commit to and embrace our principles of being Patient-Centric, Science-Based, and Performance-Driven.
-
Responsible for leading the Drug Product development and validation of all commercial and clinical products under cGLP and cGMP guidelines.
-
The Senior Clinical eTMF Manager within Clinical Digital Solutions team is responsible for the records management systems and processes involved in the planning, initiation, conduct, tracking, and completion of clinical trials in accordance with regulations and SOPs. Collaborates with the clinical study team, including CROs, to set up, manage and oversee the study electronic trial master file (eTMF). Works directly with the Senior Director, Clinical Digital Solutions on records management portfolio-wide strategic processes and risks/issues to ensure that appropriate standards, global directory, training, compliance documents and other related business processes are in place for the entire function. Examines with the Senior Director the industry benchmarking and best practices to inform current state and future state capabilities and processes.
-
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.
-
Provide Quality assistance and oversight during manufacturing of in-process, upstream and downstream, and other GMP processes as required. 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. Shift Wed-Saturday 1st shift
-
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.
-
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.
-
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.
-
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.
-
Responsible for providing support to manufacturing to maintain the production environment through the cleaning, sanitizing and disinfecting of clean rooms and equipment as well as preparing needed materials for use in both the upstream and downstream manufacturing areas.
-
The Quality Assurance Specialist focuses on the Product Disposition function, encompassing the review of production batch records and associated documentation required to release a production lot. This individual manages the batch documentation package and maintains records. This position may also be cross-trained for Raw Material Disposition, Clinical Shipments support and to provide oversight to operations on the manufacturing shop floor.
-
Responsible for pharmaceutical manufacturing in compliance with current Good Manufacturing Practice (cGMP)
-
Responsible for providing support to manufacturing to maintain the production environment through the cleaning, sanitizing, and disinfecting of clean rooms and equipment as well as preparing needed materials for use in both the upstream and downstream manufacturing areas.
-
Implement and maintain processes in Veeva Quality Management system for Quality Systems including but not limited to Document Control and Change Control.