- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning , Regulatory Operations is ... activities for Daiichi Sankyo major submissions globally. The Director of Dossier Planning will ensure high quality regulatory submissions to health authorities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at ... study level with responsibility for clinical study plan and execution (from planning start-up, conduct, reporting and close out) including timeline, quality and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and implementation of best practices. Relationships The Manager, reports to the Director , CMR Business Planning & Strategy. The incumbent works closely ... to make a difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating...alignment with NNI or CMR strategies. The CMR Business Planning & Strategy Manager will need to build strong… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will ... The CS group lead will also contribute to the program study strategy, planning , execution, and reporting outputs in collaboration with the CS Asset Leads. The… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning , directing, coordinating and prioritizing ... periodic safety reports, signal detection activities and risk management planning . The incumbent works cross-functionally with counterparts/teams in Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the ... Senior Director , GMA Oncology ADC (Global Medical Affairs team lead...life cycle management for select indications/projects. Gains strategic and planning alignment across regions and functions and supports review… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... of phase 1/2, and inspections- May support the GCL, if applicable, in planning and executing the overall publication and clinical communication strategy (overall or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for developing the Global ... -Serves as Global Medical Affairs Team (GMAT) Lead, to gain strategic and planning alignment across the matrix team consisting of regional medical affairs and core… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Director , Global Oncology Pricing & Access will both develop and execute the ... as assigned. This person will report to the Sr Director , Global Pricing & Access, and will be responsible...plan by collaborating cross-functionally- Provide pricing input to key planning processes for Brand planning and portfolio… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary:The Director , Global Medical Affairs (GMA), Gyn Oncology, under the direction of the ... Senior Director , GMA Oncology (Global Medical Affairs team lead for...cycle management for gynecological oncology indications/projects. Gains strategic and planning alignment across regions and functions, and supports review… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Clinical Development in Project Teams, possibly as Global Clinical Lead.Responsibilities:Medical Monitoring Planning (MD Only): For large Phase 2 or Phase 3 studies: ... refine study plans; Prepares and participate in regulatory agency meetings, if applicable.Study Planning and Execution: As CSL for Phase 2 Studies: Provides input on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has leadership and ... teams reporting into this role must ensure robust strategic and operational planning has been incorporated throughout the governance process, to oversee delivery of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Director of Portfolio Management, Global Project Management and Leadership (GPM&L) ... Managers are trained on Portfolio Management processes and systems as appropriate.Strategic Planning : Contribute to or lead non-drug projects related to RD strategy.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …within an indication or project; Attends EOP2 meeting and represents clinical/TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase 3 ... registrational study(ies); Develop prospective contingency plans for management of key risks in a large study or project; Clearly define study priorities and high level execution plan, communicate to members of study team within sponsor, CRO and vendors;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of ... as the subject matter expert to data management staff during the planning /start-up, conduct and close-out of external data management activities by managing external… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of interaction, decisions and outcomes. Leads routine strategy and executional planning . Contributes to development of strategies for other HA interactions (eg, ... EMA, PMDA, etc.).Dossier Submissions: Provides oversight of the preparation, coordination or monitoring of US and/or global regulatory submissions. Advises on US and/or global dossier submission strategies and identifies deficiencies requiring further… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of these objectives. This position will report to the Sr. Director , Group Leader, GPM&L. Responsibilities Project Responsibilities: Independently manage and drive ... the project environment to address gaps that impact the program/project.Manages the planning and use of program/project resources. Works with finance and team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , People Analytics will execute and drive the strategic vision for People ... Strategic Leadership Stakeholder Engagement:In collaboration and partnership with the Director , HR Systems People Analytics, this role will drive the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of regulated BA, DMPK, biological sciences, clinical pharmacology, BA strategic planning , regulatory guidance, and in-licensing and has managerial experience. This ... position will be a core member of the QCP Leadership Team and contribute to department vision, direction and future investments.Responsibilities- Oversees bioanalysis strategy from global development and global regulatory perspectives- Facilitates/oversees… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead and core DAST membership to build ... and internal information including overall product development plans.- Proactive planning for asset milestones to account for disease perspective, anticipated… more
