- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The Executive Director (ED) will lead Global Medical Safety Strategy for all Insmed's investigational and ... integration of new technology and processes to enhance patient safety and benefit risk management. The ED will provide day-to-day leadership and guidance to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Sr. Director , Clinical Safety MD, will lead the development and implementation of ... integrated project/product risk management strategies aimed at achieving the optimum benefit-...member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other… more
- Merck & Co. (Rahway, NJ)
- …development, such as manufacturing process development and validation, design control, risk management, material and molding, design validation to create and execute ... design verification strategies that successfully supports the clinical instruction(s) and commercial market approval(s) of combination products.Principal… more
- Insmed Incorporated (San Diego, CA)
- …for the future of science, we're in. Are you?About the Role:Reporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical ... compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on other related activities performed by Clinical… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand ... developing and executing strategic plans for production, packaging, distribution, and clinical supply budgeting. The Director provides strategic leadership for… more
- Merck & Co. (North Wales, PA)
- Job Description Role Summary: The Global Senior Director Medical Affairs (GDMA) is a subject matter expert in their area of responsibility (eg, defined tumor, asset, ... Serves as the medical representative within Product Development sub-teams (including Clinical , V&I, Commercial, Publications, and Label), leveraging the GMSA vision… more
- Merck & Co. (Rahway, NJ)
- …and dedicated colleagues while developing and expanding your career.The Executive Director , Chemistry, Manufacturing & Controls ( CMC) , Pre-approval Pharm will ... antibody-drug conjugates (ADCs), and traditional solid-oral small molecules.- The Executive Director will help drive our company's growth into new modalities and… more
- Merck & Co. (Rahway, NJ)
- …global filing and launch strategy, long-range demand vs capacity planning, integrated risk management, cost of goods projections, post approval change management and ... and method technical changes, robustness/quality/ productivity projects. Manage product supply risk through Integrated Risk Management (IRM) and Business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of Medical Affairs QA is ... across all Medical Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior levels. The Director … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... Documentation, Quality, Supplier and Contract Management and Digital Enablement). The Director Patient Safety Data Acquisition will provide strategic and operational… more
- Insmed Incorporated (NJ)
- …expertise in root cause analysis, investigations, change control, and Quality risk management.Direct experience with clinical manufacturing, analytical method ... of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for...The position is critical in shaping quality strategy, managing risk , and supporting regulatory readiness for complex, evolving pipelines.What… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data Management) sets the vision, ... disciplines and cultures. Additionally, he/she will possess advanced knowledge of clinical operations and relevant regulatory requirements. The individual will have… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily ... best practices, foster a culture of continuous improvement in benefit- risk evaluation, and participate in inspection readiness activities.Responsibilities:This individual… more
- Insmed Incorporated (San Diego, CA)
- …and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on cross-functional teams, where ... regulatory representative on cross functional teamsCommunicating regulatory strategies and risk assessments to cross-functional teams and senior leadership, as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: Director , Global QA Strategy &Operations (Global R&D PV QA) is responsible for ... presentation skills, power point, Visio, budget, resources, algorithms, projections, risk management and mitigation. Operational Oversight and Reporting: Oversee the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Director of Operations is an exempt level position working...production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C… more
- Insmed Incorporated (NJ)
- …lead activities associated with moving Insmed's late-stage pipeline through clinical development, regulatory submissions and commercial launch. This position will ... leading program manager role for major programs. As a leader, the Executive Director will work with multiple partners across Insmed to ensure consistent and… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- MetroPlusHealth (New York, NY)
- …strong relationships with its members and providers.Position OverviewUnder the direction of the Director of Care Management (PIC), the PIC Clinical Care Manager ... and coaching on HIV disease, HIV primary and secondary risk reduction, and other chronic co-morbid illness, including, but...Social Work is required.A minimum of two years of clinical experience in HIV care or support systems that… more
- Bethesda Health (Kirkwood, MO)
- …preferred. SummaryProvides management oversight for multiple nursing neighborhoods and assists the Director of Nursing as needed. Acts as a resource to staff ... concerns and needs. Communicates events requiring administrative attention to the Director of Nursing. Recommends corrective action when problems are identified,… more
