- Novo Nordisk Inc. (Plainsboro, NJ)
- …deliverables that support the clinical development and regulatory requirements of a clinical program . The Director will provide high level strategic ... NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating...Are you ready to make a difference?The Position The Director , Medical Writing is an expert in medical writing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functional group and high-complexity disease work to support critical strategic choices for the clinical program . The DAST Director will collaborate with the ... Facilitate pull-through of the disease area strategy through collaboration with clinical development team (ADC portfolio plus emerging pipeline assets) and key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ... or escalate study issues /risk mitigations to the Operations Program Lead and study team leader.Ensure adherence to internal...is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study ... and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program … more
- Merck & Co. (North Wales, PA)
- …of clinical data/medical protocol deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members ... drives scientific planning, strategy and execution of Phase 1-4 clinical studies. Under the direction of the Program... clinical studies. Under the direction of the Program Lead, you will collaborate with global, cross-functional team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development, ... and being influential in reaching prompt decision making to support DS Program developments. This position provides expertise within the Biostatistics and Data… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Clinical Pharmacology role within Clinical Development ... organization will provide leadership and expertise to support assigned clinical pharmacology projects in the clinical development programs for an expanding… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead ... DS stakeholders on the disease area and compound/DrugMay serve as speaker for program / franchise medical/scientific training - Guide the Clinical Science staff… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; ... of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical … more
- Insmed Incorporated (San Diego, CA)
- …lists.OverviewThe primary responsibilities are to manage all aspects of clinical operations including study planning, financial oversight, project deadlines and ... ensuring compliance with Good Clinical Practices as well as federal and local laws.ResponsibilitiesAdditional representative responsibilities will include, but not… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in order to proactively perform safety surveillance and ... as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in order to proactively perform safety surveillance and… more
- Insmed Incorporated (Bridgewater, NJ)
- …highly strategic view is required. This opportunity will require a focus on all the clinical aspects of the upcoming HS program . Strong leadership skills are a ... amendments and Special Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program level… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III ... clinical trials; Reviews regulatory documents from cross functional, holistic...KOLS for advice on complex development or safety issuesScientific, Program related: Integrated Study Team (IST) representative or IST… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met...financial metrics on an ongoing basis to study and program teams. In collaboration with internal and external partners,… more
- Tris Pharma (Monmouth Junction, NJ)
- …the Pain therapeutic area to serve as Senior or Executive Medical Director . Title and salary commensurate with experience. The Executive/Senior Medical Director ... provides leadership, direction and medical expertise for company’s clinical development programs specifically focused on the treatment of Pain. The incumbent is… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Scientific Communications is a core member of Medical Strategy and ... implementation of global Medical Communications Strategy across regions. The Director will develop collaborative partnerships with the cross-functional Insmed team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Science. Work with the VP Medical/Scientific Development, Clinical Operations, Non- Clinical Research, Medical Writing, Program Management, CMC and Regulatory ... Essential Functions Support the VP Medical/Scientific Development as the US/international clinical lead for DCR-PHXC program to both internally and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization ... dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials. Position Summary / Objective Serves as a primary source of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior ... Director , GMA Oncology (Global Medical Affairs team lead for...lead for compound), is responsible for assisting with defining compound/ program medical strategies and for leading select medical affairs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …initiative in support of these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director , US Head GPM&L. ... execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high performing ...the project environment to address gaps that impact the program /project.Manages the planning and use of program /project… more
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