- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has ... leadership and overall strategic oversight of study management and delivery for all therapeutic areas. The...role such as a Global Project Leader at Sr. Director level or equivalent preferred- Relevant therapeutic experience and… more
- Merck & Co. (North Wales, PA)
- …the Clinical Trial Team leadLeads and directs teams in key study planning, development, and execution elements (eg operational reviews, issue escalation/mitigations, ... governance).Responsible for facilitating and collaborating with key internal/external stakeholders ( study team, subsidiary country teams, vendors, committees, etc.) in… more
- Merck & Co. (North Wales, PA)
- …position drives scientific planning, strategy and execution of Phase 1-4 clinical studies .-Under the direction of the Program Lead, you will collaborate with global, ... cross- functional team-members including clinical directors and study managers to lead/support clinical trial scientific-activities.Job ResponsibilitiesResponsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … study results; Present results to regulatory agencies during pre-submission meetings; Interpret study results in context of other studies in the project and ... Team Leader (ITL-ISTL)ResponsibilitiesStudy Strategy: For Phase 2 and Phase 3 registrational studies : Provides the strategic direction to BD&O for EDC, edit checks,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position Drive study management activities and manage cross-functional study team, external service providers ... timelines, and financial metrics on an ongoing basis to study and program teams. In collaboration with internal and...and guidance to other areas within NACD including Operations Director and TA Heads People Management: Provides daily people… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of a ... and provide safety leadership including but not limited to clinical studies , post-marketing surveillance, signal detection and management, important safety topics,… more
- Eisai, Inc (Nutley, NJ)
- …of trial results, final study report conclusions and publications. Serve as study director for trials. Provide critical medical input into the lifecycle ... your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive… more
- Merck & Co. (North Wales, PA)
- …and dedicated colleagues while developing and expanding your career.The Clinical Director (Principal Scientist) has primary responsibility for the planning and ... medicines span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including: … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clin pharm patient studies , and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study ... to appropriate Governance Committee. Analyze CRO performance trends within a clinical study or across several studies and resolve or escalate accordingly.People… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relevant regulatory requirements. This position has experience working on Phase I-IV study studies within the medical device and/or pharmaceutical industry ... DM activities and deliverablesEstablishes Data Management strategy at the project and/or study level for a larger number of projects/ studies with greater… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disabilities.SummaryThis position supports early phase oncology development and leads complex studies in study design, statistical analysis and interpretation of ... and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the clinical operational and overall delivery and tactical execution of the clinical studies . The senior director will ensure a strong focus on competencies ... research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational Medicine/Clin ... Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides input on major milestones of trial, clinical trial plan and contingency… more
- Eisai, Inc (Nutley, NJ)
- …on project teams. This involves providing valuable statistical input on observational studies , actively participating in the formulation of study designs and ... diverse data sources (eg, clinical trial data, patient registries, and observational studies ) to support study design and otcomes measured.Align the… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned projects ... simultaneously.Reviews and provides final approval Worldwide Marketing Applications, Clinical Study Reports, Protocols, Investigators' Brochures before release from our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support ... or independently leads the design, preparation and analysis of epidemiologic studies , including real-word evidence (RWE), supporting senior management in various… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …control of Clinical Project Budget in support of Phase I-III clinical studies . Partner with Project Management, Clinical Operations and other functional groups to ... global business partners to develop budgets and analytics for ongoing and new pipeline studies in support of the annual process of extracting the optimal value out… more
- Merck & Co. (Rahway, NJ)
- …strategies.Ensures the statistical designs and analysis methods utilized in clinical studies are scientifically sound and meet worldwide regulatory and marketing ... needs.Perform comprehensive review of protocols, statistical analysis plans, clinical study reports, and submission documents to ensure accuracy of the statistical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this position are the plan, design, and conductance of early development clinical studies ; the preparation of regulatory documents to file IND and report studies ... of the specialty medicine (SM) clinical development (CD) function on study and project teams. This position requires significant understanding of clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …interpret Phase 1 (specifically Clinical Pharmacology) studies , support Phase 2/3 studies , represent function on study and project teams, and participate in ... functions as Study Team Leader for Phase 1 Clinical Pharmacology studies , and provides clinical pharmacology input and support for other phase 1-4 clinical… more
