- 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
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Cardiometabolic Our Clinical Research and Pharmacovigilance team push the boundaries of global ... 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
- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... 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)
- … Senior Director Medical Affairs (GDMA) - Daiichi Alliance, OncologyThe Global Senior Director Medical Affairs (GDMA) is responsible for driving ... ( Clinical , Value Evidence, Commercial, Publications and Label) and Global Human Health commercialization teamsContributes to the development of a single… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …therapeutics Provide clinical and scientific expertise to the design of studies , writing of protocols and other study and regulatory-related documents for ... make a difference?The Position We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific...groups and utilize novel and creative methods to resolve clinical development problems Work with the larger Global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …be the Clinical Science Group Lead in late phase development in the Global Clinical Science functionHe/she will be responsible for managing the multiple ... data integrity, site scientific engagement, and HA responsesInteractions with the internal clinical study physicians and physician scientists as well as external… 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. (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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the effective ... Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads... Clinical Scientists (CS)- Interpretation and presentation of clinical study (ies) data to internal and external… more
- Merck & Co. (North Wales, PA)
- …plans for study protocols. Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.Prepares oral presentations ... Job DescriptionOur company is a global health care leader with a diversified portfolio...procedures, and external regulatory requirements.Responds to queries relating to study design, analysis, and interpretation posed by clinical… 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)
- …in the role of- Senior Specialist.--QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects ... authoring for regulatory documents such as Investigational New Drug application, Clinical Study Report, Common Technical Document, and agency- interactions.-You… 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 ... nonclinical safety data package, oversee safety pharmacology and toxicology studies , author nonclinical sections in regulatory submission documents, and address… 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
- 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)
- …as well as statistical support for translational oncology projects and studies .-Interact with Clinical , Regulatory, Statistical Programming, Data Management, and ... drugs and vaccines for the benefit of patients and global human health. The incumbent is responsible for statistical...statistical planning and data analysis of Phase I/II oncology clinical trials as well as translational biomarker analyses. This… 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
