- 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
- 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
- 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)
- …matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) ... Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and...regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before DBL, and quality check… 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) ... Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and...regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before DBL, and quality check… 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)
- … 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
- 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)
- …Provides medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility ... Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the...to achieve the Target Product Profile (TPP)- Development of clinical sections of trial -level regulatory documents (eg,… more
- Insmed Incorporated (San Diego, CA)
- …Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical programs across different diseases and supervising the ... of clinical studies, review & interpretation of clinical trial data, authoring clinical ...trials, through to full development.Serve as the therapeutic area lead of the ophthalmology clinical development team,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Clinical Operations lead Support investigator meetings Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations point, ... on insights from the marketplace. This role may also lead the Core Medical Team, Project Team (co-chair), and...Medical Affairs team on relevant disease state topics and clinical trial data. Review and approve resources… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility ... when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …people required7 or More Years managing initiatives requiredCompetenciesEnd-to-end clinical trial experience directing/overseeing data management services ... to function as DM SME in internal audits and/or regulatory on-site inspectionsKnowledge of clinical trial operations, clinical trial data flow,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decisions (phase I trials) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure ... Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of safety profile of assigned...Responsible for all areas related to patient safety in clinical trials Act as member of the trial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in a timely fashion. In addition, the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to the field team, and ... the region to enhance territory management of field teams Lead project teams to manage and support various projects...training initiatives for the medical affairs team Serve on Clinical Trial Strategy Team to identify investigators/sites… more
- Merck & Co. (Rahway, NJ)
- …Lead research activities for innovative statistical methods and applications in clinical trial development. Collaborates in publication of research results in ... processing software eg SAS and/or R.-Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.-Excellent oral and… 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
