- Tris Pharma (Monmouth Junction, NJ)
- …of clinical study processes and procedures ensuring timely execution of quality clinical trials complying with all regulations and/or guidance. Collaborating ... in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director ,... development portfolio. The incumbent is accountable for the Clinical Operations cross functional collaboration to develop program… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has ... all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the... trial portfolio and submissions are delivered to time, quality , and cost. The teams reporting into this role… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... diseases and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III … more
- Catalent (Harman, WV)
- Senior Director , Supply Chain Position Summary: The Senior Director , Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study ... and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Access departments as needed Project management liaison: Assist in developing clinical program time lines, budgets, and strategies Other essentials: ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development. Internal relationships… more
- Novo Nordisk Inc. (Chicago, IL)
- …head). They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Insmed Incorporated (Bridgewater, NJ)
- …the biopharma industry, come to Insmed to accelerate your career. OverviewThe Director of Field Medical Excellence (FME) will develop field medical functional ... strategy to enable high- quality , impactful customer engagements with a consistent approach worldwide....customer engagements with a consistent approach worldwide. The FME Director will also drive operational excellence across the regions.… more
- Merck & Co. (North Wales, PA)
- …development of and maintain publication strategy and plans in the assigned oncology program . The Associate Director Pub Manager delivers the tactics identified ... Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible for… 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....evidence-based M&A advisory services. Reporting into the Senior Medical Director , M&A Scientific Advisory, the Medical Director ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....bespoke, evidence-based M&A advisory services. Reporting into the Executive Director of M&A Advisory, the Director , M&A… more
- Merck & Co. (Rahway, NJ)
- …2 years of management responsibility and experience developing staffFluency in the clinical quality management system and CMC process, across modalities and ... siting and compliance councils. Key performance indicators range from quality and regulatory compliance, operational excellence, pipeline program support,… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... management, CAPA tracking, change control, risk management, supplier quality , audits and inspections, raw materials release, and compiling, trending and reporting… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of ... Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leadership teams to ensure Quality is consistently and proactively represented at program level and along the clinical trial process in support of a ... point person for all GxP matters for the Global Program Head and the Global Program Team....ensure in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality … more
- Insmed Incorporated (Bridgewater, NJ)
- …for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large ... bioanalytical methods and sample analyses of regulated bioanalytical assays for clinical , nonclinical and biomarkers studies. This translational role resides within… more
- Eisai, Inc (Nutley, NJ)
- …describe complex disease processes to understand and evaluate the implications of clinical trials and real-world data; demonstrate the value of interventions beyond ... assessment of Eisai Neurology products, and will be responsible to deliver high quality and impactful models to ensure optimal patient access. In addition, the… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. ... executing the safety and risk management activities for one or more clinical development or marketed products throughout their lifecycle. This position reports to… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Biostatistics is a highly visible role within the Clinical ... plan, researches and leads the statistical design, analysis, and reporting of clinical trials, and interacts with global regulatory agencies. This role also leads… more
