- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) ... to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical...Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . Responsibilities:Study Strategy: Clinical study leader (CSL) ... to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical...Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and… more
- Merck & Co. (Boston, MA)
- … clinical development strategies for investigational drugs and planning clinical trials (design, operational plans, settings) based on these ... development strategiesMonitoring and managing the conduct of ongoing or new clinical trials for investigational drugsAnalyzing and summarizing the clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is expected. The CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical Study ... veterans and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical … more
- Merck & Co. (North Wales, PA)
- …including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be ... directors responsible for clinical programs.Supervises development of clinical documents including development plans, protocols, trial related documents,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical supplies across the DSI portfolio. This role as CSO ( Clinical Supply Planning and Operations) Project Lead is primarily responsible for ... rare diseases and immune disorders. Summary NOTE: This Project Lead Role is an Individual Contributor and sits at...service providers and working with internal departments to progress clinical supply projects. Every effort has been made to… more
- Insmed Incorporated (San Diego, CA)
- …Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical programs across different diseases and supervise the ... of clinical studies, review & interpretation of clinical trial data, authoring clinical ...the company to external stakeholders supporting the conduct of clinical trials , including CROs, clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external ... input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the... Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials . Serves as a primary source of medical accountability ... and oversight for one or more clinical trials Matrix management responsibilities across the...input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and ... disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in...activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and quality.Establish… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... clinical trials , in collaboration with Clinical Director and Clinical Operations lead...Operations lead Support investigator meetings Serve on Clinical Trial Strategy Team in collaboration with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in clinical trials required.Demonstrated ability to define clear clinical trial translational strategies anchored in disease biology and drug mechanism ... In addition, he or she will interact with the Companion Diagnostics Lead , Non- Clinical Research, Medical Affairs and other stakeholders to support the program.… more
- Merck & Co. (Rahway, NJ)
- …Management, and other Company Research Laboratories Scientists in designing and analyzing clinical trials , and in coordinating the statistical activities for ... other potential problems arising in the design, conduct, and analysis of clinical trials , proposes solutions and carries them out.Develops individual protocols… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... study leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Registrational Trials being considered for RD prioritization. Coordinate and lead meetings to gain OBU leadership consensus on Commercial input and ... prioritization rankings via presentation of Forecasts/Assumptions/NPVs and comparative Clinical value where possible. Lead BSA Forecasting team members through… more
- Merck & Co. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/Late Development Statistics, ... project management skills. --Good understanding of worldwide regulatory requirements and clinical trial expertise .Strong oral and written communication skills.… more
- Merck & Co. (North Wales, PA)
- …software eg SAS and/or R.Thorough understanding of worldwide regulatory requirements and broad clinical trial expertise from phase I to V.-Strong oral and ... and statistical analysis methods fundamental to effective pharmaceutical R&D. The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment,… more
- Merck & Co. (Rahway, NJ)
- …validation and transfer of release, characterization, and stability assays for testing of clinical trial material and in support of product and process ... join our Large Molecule Analytical Validation team to serve as an Analytical Program- Lead . The lead must take charge in overseeing and guiding analytical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actual product Responsible for all areas related to patient safety in clinical trials Act as member of the trial safety group for dose escalation decisions ... Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of safety profile of assigned...) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Data Management and Clinical Development. Responsibilities Designs and leads clinical trial sample testing activities and data capture to support CDx ... regulatory submission or associated drug regulatory submissionsResponsible for implementation of clinical trial assays at Diagnostics Partners, reference labs… more
