- Merck & Co. (North Wales, PA)
- Job DescriptionThe Senior Statistical Programmer, Study Data Tabulation Model (SDTM), provides oversight and creation of the SDTM deliverables for analysis and ... a clinical trial environment.Required Experience and Skills: Experience with study data standards CDISC (SDTM)Experience in SAS and clinical … 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
- 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)
- 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
- Insmed Incorporated (Bridgewater, NJ)
- …delivery of Clinical Operations objectives by providing operational support to the clinical study team (CST) with the responsibility to manage multiple ... specific, drug, program, and therapeutic area level), and maintains training matrices for the clinical study team.Actively participates in clinical study … 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)
- …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
- 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. (Rahway, NJ)
- …assigned to a development project as neededLead biostatistics in early or late clinical development planning to ensure that study designs are consistent with ... drugs and vaccines for the benefit of patients and global human health. Responsibilities :Serves as a statistical lead...of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet objectives of the study… 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
- 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
- Eisai, Inc (NJ)
- … strategies. Essential Functions Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor ... management; providing guidance to study teams on vendor selection and management options in...and managing service provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance… more
- Merck & Co. (North Wales, PA)
- …program development of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.- ... to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.-Is responsible for planning and ensuring… 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
- 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
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 ... Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… 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 ... Budget; Establishes effective communication between CRO / vendors / AROAdditional non- study related activities: Occasional senior management interactions at… more
