- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and ... documentsServes as a specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies , literature, and regulatory guidelines and can conduct/develop PK-PD… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. Responsibilities Study Strategy: Provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Job Summary: The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good ... and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction... Study Manager role is primarily a tactical study delivery role, reporting into an Associate … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant working experience in externally sponsored research, including IIS and collaborative studies required4 or More Years in a clinical management setting ... research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium ... and immune disorders. Summary Position leads statistical support for medium complexity studies including contributing to development of optimal study design,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timelines. Clinical regulatory documents include, but are not limited to, clinical study reports, investigator brochures, regulatory briefing documents, and ... contribute to strategic planning and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor selection criteria.- Problem solves and negotiates in most service types, studies , and programs- Responsible for the development and management of other ad ... preferred Experience- 7 or More Years Outsourcing, health sciences or related field ( clinical trials) required- 7 or More Years Deep experience in pharma procurement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of assigned GMA Oncology productsManage timelines of publication outputFacilitate study Publication Committee discussionsLiaise with internal & external authors, ... academic research organizations, and study investigatorsManage vendor budget and activitiesOversee the quality and timeline of vendor workCollaborate with study … more
- Merck & Co. (Rahway, NJ)
- …To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing ... innovation and interest in contributing to upstream and/or downstream bioprocessing.As an Associate Scientist in BPD you will work with a highly collaborative team… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development team based ... of developing innovative cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy program. If you're… more
- Merck & Co. (Rahway, NJ)
- …and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications ... and Pharmacometrics - Immune/Oncology team in the role of Associate Director. The team is part of the Global... Director. The team is part of the Global Clinical Development organization and has oversight over drug development… more
- Abbott (New York, NY)
- …generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Clinical Associate ** **About Abbott** Abbott is a global healthcare leader, ... following areas: + Sales support; + Regional training seminars; + Clinical studies /data collection; + Trouble Shooting; and, + New product in-service training… more
- The Mount Sinai Health System (New York, NY)
- …part of the research study team and monitors all safety aspects of clinical research trial(s). Under guidance of the Associate Director of Research and ... Events (SAE) for safety reporting, CEC and DSMB of clinical studies to ensure compliance with regulations...is responsible for reconciliation of drug safety databases and clinical study databases for adverse event reporting… more
- System One (Basking Ridge, NJ)
- Role: Clinical Study Associate I Type:...Assist in planning and execution of clinical studies , under the supervision of the Study Manager ... the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ...attention. Skills: Demonstrates knowledge of complex processes related to clinical studies , regulatory issues, CRO operations, and… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …Clinical Research Associate (CRA) is a key contributor to early phase/ clinical pharmacology studies . The CRA is responsible for the quality and compliance ... all we do, create and deliver. The in-house Clinical Research Associate / Senior ...and departmental meetings + May request cost estimates for clinical studies , manage purchase orders and invoices,… more
- Fairleigh Dickinson University (Teaneck, NJ)
- Job Summary: Clinical Assistant/ Associate Professor & Clinical Director, Physician Assistant Program will develop, maintain, and ensure adequacy and quality ... Director. This position, non-tenured and at the rank of clinical assistant or associate professor, serves as...partnerships inside and outside the program in physician assistant studies , the School of Pharmacy and Health Sciences and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- Clinical Study Associate Manager (CSAM)... sites may be required to assist with monitoring clinical studies . **A typical day might include the ... role supports the Clinical Study Lead (CSL) by taking responsibility for... trial delivery. This role applies to internally sourced studies and studies outsourced to Clinical… more
- Kelly Services (Basking Ridge, NJ)
- …**The Experts at Hiring Experts.** No C2C Full-time, perm, direct hire The Clinical Research Associate (CRA) is responsible for the implementation, monitoring, ... **Kelly(R) Science & Clinical ** is seeking a Senior Clinical ...Responsibilities:** + Serve as the primary liaison for assigned study sites, conveying project information, answering questions, and resolving… more
- Kean University (Union, NJ)
- …of Physician Assistant Studies ** **_Physician Assistant Studies_** **(12 Month Clinical Assistant/ Associate Professor) -** the MS in Physician Assistant ... six doctoral degree programs and more than 70 options for graduate study leading to master's degrees, professional diplomas or certifications. The University is… more
