- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role...Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the Study ... goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as ... trials within an indication or project; Attends EOP2 meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director, Global Oncology Medical Affairs is responsible for ... function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global … more
- Merck & Co. (North Wales, PA)
- …Summary: This position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the ... leadership, technical skills, and scientific acumen as part of a global , cross-functional team.Job Responsibilities: Responsible for leading specific aspects of … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as ... for protocol profile, protocol and amendments for small, uncomplicated clinical studies ; Coordinate sponsor medical monitors across...Study Team (IST) representative or IST leader on study team; Responsible before senior management for… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary:The Global Senior Director Medical Affairs (GDMA) Immunology/Pipeline & Biomarkers will be responsible for driving execution of ... ( Clinical , Value Evidence, Commercial, Publications and Label) and Global Human Health commercialization teams.Contributes to the development of a single… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …resolve or escalate to appropriate Governance Committee. Analyze CRO performance trends within a clinical study or across several studies and resolve or ... clin pharm patient studies , and Phases 1-3 clinical trials at the study and program...successful execution of all operational components of a large-scale global clinical program using strong clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director, Global Oncology Medical Affairs, Evidence Generation role ... progress to relevant internal stakeholders using trackers and tools generated by Global Oncology Medical Affairs Study Operations partners and propose mitigation… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will ... and Clinical Directors responsible for the design and medical monitoring of clinical studies .Ensure optimal design and monitoring of clinical programs… more
- Merck & Co. (Rahway, NJ)
- …existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is ... standards development teamsThe Vocabulary Specialist maintains knowledge of new technologies, clinical study data standards, regulatory requirements emerging in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Phase 1 (specifically Clinical Pharmacology) studies , support Phase 2/3 studies , represent function on study and project teams, and participate in and ... at a project level, and interacts with regional and global project team members, senior management, and...as Study Team Leader for Phase 1 Clinical Pharmacology studies , and provides clinical… more
- Merck & Co. (Rahway, NJ)
- …priority programs and studies .Adhere to company standards and Research Laboratory/ Global Clinical Development (GCD) and GCTO goals, initiatives and ... CRO run studies . Will adhere to Good Clinical Practices (GCP), local and global policies...matrix organization with all groups within GCTO, especially with Clinical Sciences and Study Management (CSSM), … more
- Merck & Co. (South San Francisco, CA)
- …writing and preparing nonclinical pharmacology regulatory document submission sections and study reports to support the development of therapeutic agents and ... Experience and Skills: Strong writing skills and experience drafting study reports, scientific manuscripts, or scientific documentsStrong computer skills, especially… more
- Merck & Co. (Rahway, NJ)
- …support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint ... to post-licensure). The Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory… more
- Merck & Co. (Rahway, NJ)
- …support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint ... may:Supervise the activities of Clinical Scientists in the execution of clinical studies ;Work closely with a cross-functional group of experts in… more
- Merck & Co. (North Wales, PA)
- …The Senior Director will manage the entire cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, ... talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 ... specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies , literature, and regulatory guidelines and...regulatory interactions at project level, interacts with regional and global study and project team members, and… more
- Insmed Incorporated (Bridgewater, NJ)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Director, Toxicology is a key member of the nonclinical safety team,… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
