- Merck & Co. (Rahway, NJ)
- …the further study of marketed compounds.In executing these duties, the Senior Director may:Supervise the activities of Clinical Scientists in the execution ... Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed...safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical ... country teams, vendors, committees, investigators, site personnel, etc.) in support of clinical study objectives.- Accountable for managing any study … 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire...safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in… more
- Merck & Co. (Rahway, NJ)
- …(Principal Scientist)has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. ... safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in...of Clinical Scientists in the execution of clinical studies ;Work closely with a cross-functional group… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … trials within an indication or project; Attends EOP2 meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for ... Present results to regulatory agencies during pre-submission meetings; Interpret study results in context of other studies ...Study Team (IST) representative or IST leader on study team; Responsible before senior management for… more
- Eisai, Inc (Nutley, NJ)
- …led by Translational Science to evaluate biomarkers across programs, as well as the study statistician for clinical studies . As the statistical lead for ... managing CROs. The immediate need is to manage early clinical development studies primarily in support of...conduct to proactively address issues to ensure high quality study data (as needed). Clinical Study … more
- Merck & Co. (Rahway, NJ)
- …Activities may include, but are not limited to: Creates and develops clinical databases and data transfer files according to written specifications. Ensures ... adherence to clinical database standards, SOPs and Process Guidelines. Leads and... Data Management System (CDMS). Interface with members of study teams, including external CROs/Vendors where applicable, to integrate… 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
- 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...in Pharmacology or Pharmaceutical Sciences or PharmD with a clinical pharmacology research fellowship and 4 years… more
- Merck & Co. (North Wales, PA)
- …, Regulatory, Statistical Programming, Data Management and other of our company's Research Laboratories Scientists in designing and analyzing clinical trials, ... program development of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.-… more
- Insmed Incorporated (Bridgewater, NJ)
- …and interpretation of nonclinical safety data; and oversee nonclinical safety studies outsourced to contract research organizations.Provide strategic input to ... day, our employees turn their passion for science and research into innovative solutions for patients. That's why we...in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Director, Toxicology is a key member of the… 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...multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The Senior ... as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global Product Team to… 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 ... as Study Team Leader for Phase 1 Clinical Pharmacology studies , and provides clinical...in pharmacology or pharmaceutical sciences or PharmD with a clinical pharmacology research fellowship required Experience Qualifications7… more
- Merck & Co. (Rahway, NJ)
- …Clinical , Regulatory, Statistical Programming, Data Management, and other Company Research Laboratories Scientists in designing and analyzing clinical trials, ... and in coordinating the statistical activities for clinical drug/vaccine projects.Interacts with Academic Research Organization (ARO), Contract Research … more
- Merck & Co. (Rahway, NJ)
- …submission strategies.Ensures the statistical designs and analysis methods utilized in clinical studies are scientifically sound and meet worldwide regulatory ... and marketing needs.Perform comprehensive review of protocols, statistical analysis plans, clinical study reports, and submission documents to ensure accuracy of… more
- Eisai, Inc (NJ)
- …will oversee and lead and support activities related to the outsourcing of clinical services to Clinical Research Organizations (CROs) and functional ... is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines,… more
- Eisai, Inc (Nutley, NJ)
- …of the pharmaceutical marketplaceFDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area.Knowledge of regulatory ... is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines,… 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
