- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical … more
- Merck & Co. (Rahway, NJ)
- …and SAP team members to further extend capabilities and functionalities on our existing Clinical Trial Supply Management (CTSM) solution in order to satisfy and ... Management and Distribution areas with a strong focus in Clinical Trial Supply Management (CTSM) is highly...support of- SAP applications across all functional areas supporting Clinical Trials . This includes leading or contributing… more
- Merck & Co. (Rahway, NJ)
- … clinical development strategies for investigational or marketed Oncology drugsPlanning clinical trials (design, operational plans, settings) based on these ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage...strategiesMonitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology… more
- Merck & Co. (Rahway, NJ)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
- Merck & Co. (Rahway, NJ)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulation, disease progression models, ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
- Merck & Co. (Rahway, NJ)
- …non-traditional therapeutics like peptides, novel biological constructs and others, perform clinical trial simulations, comparator modeling and other model-based ... Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding immunology pipeline.As an...analyses to inform dose selection and schedule, clinical trial design and go/no-go decisions.- You… more
- Merck & Co. (Rahway, NJ)
- …or more novel quantitative approaches that seek to improve cycle time, cost/size, number of trials , clinical trial design and Go/No Go decisionsServe as a ... advanced pharmacometrics capabilities like comparator modeling, model-based meta-analysis (MBMA) and clinical trial simulations (CTS) into programs and thereby… more
- Merck & Co. (Rahway, NJ)
- …portfolio prioritization-Comfort with and strong interest in scientific underpinnings of our clinical trials and those of competitors to effectively engage ... is on innovation that help people with cancer across the globe.The Executive Director will be developing and executing the market access & reimbursement strategies… more
- Merck & Co. (Rahway, NJ)
- …Develop model-based strategies (translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within ... phases of drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisionsCollaborate with other functional areas,… more
- Merck & Co. (Rahway, NJ)
- …measurement and quality-related inquiries from regulatory agencies to support clinical trial and commercial marketing applications.Project Management and ... Job DescriptionThe Executive Director of Structure Characterization & Elucidation is responsible for providing strategic and technical leadership to enable deep… more
- Merck & Co. (Rahway, NJ)
- …development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process ... Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial Operational Risk & Oversight ... and continuously monitored for effectiveness, efficiencies, and areas of improvement.Responsibilities: Clinical Trial Operational Risk (CTOR) Management:Build and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …serving as the primary point of contact.- Review and analyze data from clinical trials , post-marketing and other relevant sources for the prompt identification ... of safety signals. Review and evaluate serious adverse event reports from clinical trials or post-marketing for completeness, accuracy, expectedness and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expertise and trending to shape the future of Daiichi Sankyo clinical trials .Responsibilities- Process Improvement, Innovation and Optimization (IO):Project ... Support the build of industry expertise in innovation and optimization for clinical trials . oUtilize strategic conferences for information mining and networking,… more
- Tris Pharma (Monmouth Junction, NJ)
- …and other existing/investigational products, liaising with key opinion leaders (KOLs), clinical trial investigators and internal scientific, pharmacology and ... facility for an experienced MD to serve as Senior Director or Director , Clinical Development....by working closely with local functions on the full clinical trial life cycle; Reviews, synthesizes and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will ... Action/Preventive Action (CAPA) plans and related effectiveness measures, as appropriate.Responsibilities: Clinical Trial Operational Risk Management:Own, lead and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... trials of medium to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and updates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Voice Strategy and Infrastructure.Build processes withing GCO to achieve diversity in clinical trials and patient focused drug development (ie. Patient voice) ... vendors, or investigative sites on the importance of representative diversity in clinical trials and patient voice.Identify innovative approaches, industry best… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... trials of medium to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory… more
