- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical ... involving investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of… more
- Tris Pharma (Monmouth Junction, NJ)
- …and team success.We have an immediate opening in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director , ... of issues for trial or program level deliverables to senior management, etc.); Develops, implements, and/or manages adequate systems...and vendor personnel selection including, but not limited to: Clinical Project Managers, Clinical Trial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and participate in regulatory agency meetings, if applicable; Defines study strategy across clinical trials within an indication or project ; Attends EOP2 meeting ... alignment ; Leads development and execution of Product Development Plan and clinical development strategy; Leads Integrated Project Team (IPT) working closely… more
- Insmed Incorporated (Bridgewater, NJ)
- …Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Director , Toxicology is a key member of the nonclinical ... safety studies outsourced to contract research organizations.Provide strategic input to project teams and senior management regarding the potential impact… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. ... aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3... team members, and to a limited extent with senior management, and outside vendors; works independently for all… 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 ... project management skills Preferred experience and skills: Deep clinical expertise in Rheumatology, Dermatology and Gastroenterology; building early phase plans… more
- Merck & Co. (Rahway, NJ)
- …analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre- clinical and translational ... further study of marketed compounds.In executing these duties, the Senior Director may:Supervise the activities of Clinical Scientists in the execution of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator ... (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical... Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director ,… more
- Merck & Co. (Rahway, NJ)
- …and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical , Regulatory, Statistical Programming, Data Management, and our ... Company's Research Laboratories Scientists in long-range project planning, providing guidance to others in the statistical support for clinical drug/vaccine… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …at a project level, and interacts with regional and global project team members, senior management, and outside vendors.ResponsibilitiesResponsible for all ... drug development plans, serves as QCP subteam leader / clinical pharmacology project team representative, supports Phase... team members, and to a limited extent with senior management and outside vendorsMentors more junior department members,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , ... execution of all operational components of a large-scale global clinical program using strong clinical project...a large-scale global clinical program using strong clinical project and program management, leadership, decision-making… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's global ... area known for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …interfaces within a matrixed environment and with varying professional levels Leads Clinical Ancillary Management project teams to ensure Clinical ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Merck & Co. (Rahway, NJ)
- …approaches to develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and ... biologics, and inform dose selection and go/no-go decisions. Senior Directors lead QP2 efforts to strengthen our pharmacometric capabilities on a continuous basis by… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Planning and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase I-III clinical studies. ... reporting capabilities. Develops and maintains a working relationship with the internal project team(s) and team leader(s) or US based Global Function leaders as… more
- Merck & Co. (Rahway, NJ)
- …to advance the drug discovery and development pipeline.We are seeking a Senior Information Architect with expertise in biopharma research to support our ... biopharma research, such as public Omics databases (eg, GenBank, GEO), clinical trial repositories (eg, ClinicalTrials.gov), patient-level data platforms (eg, OMOP,… more
- Merck & Co. (Rahway, NJ)
- …and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ensuring that appropriate Corporate personnel are ... Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of… more
- Merck & Co. (Rahway, NJ)
- …in a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position ... will report to the Director , Engineering, Automation Lead position and will be a member of the EF Team at the Rahway NJ facility. EF is responsible for development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Clinical Operations and Marketing Effectiveness. Strong collaborations with senior leaders from Legal, Finance, Operations and Market Access as well ... Accountability team and the Leadership Team as a member of various inter-department project work groups Conducts training to employees and third party vendors to… more
