- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director , Product Stewardship Our Global Safety & Environment (GSE) team is passionate about bringing our medicines and ... and our neighbors are not impacted.This role, reporting to the Executive Director of Environmental Compliance, Sustainability & Stewardship CoE will manage the… more
- Merck & Co. (Rahway, NJ)
- …for analytical development of candidates from the discovery interface, through first product registration.- -The Director will be directly responsible for a ... Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …franchise products, in alignment with key global and regional functions. The Global Director of HEOR & RWE Oncology will lead the HEOR and RWE implementation ... clinical, Medical Affairs and commercial organization and drive the product evidence strategies to ensure an effective use of...an effective use of HEOR and RWE methods. The Director will provide HEOR and RWE strategic direction to… 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 ... product safety team, and be responsible for overall product safety strategy or specific areas of safety surveillance...may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project… more
- Merck & Co. (Rahway, NJ)
- …launch preparations of new subcutaneous formulation of our Company's largest oncology product .Partnering with the LOE strategy director to drive preparation for ... Human Health, our Global Oncology Organization is currently recruiting for a Strategy Director to join the Global Oncology Strategy and Operations team reporting to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Project Teams including strategic development and execution of an integrated product development plan. This position is accountable for partnering with the ... these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director...strategy development and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Sr Director GPM&L is accountable for delivering an integrated drug development strategy and ... the Global Team Leader to drive strategy development and create an integrated product development plan and timelines. Ensure execution of overall plan and annual… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities pertinent to the overall compliance state of DS drug substance, drug product and packaging manufacturing sites of DS products. These sites include both DS ... owned and contract manufacturing organizations (CMOs). Ensure QA leadership to support the preparation, execution, and remediation of regulatory inspections of the sites. The incumbent leads a productive working relationship with internal/external stakeholders… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …display, results validation, interpretation and reporting to accelerate worldwide product submissions and approvals.Drug Development Strategy: Reviews and provides ... strategic input to entire portfolio or specific therapeutic areas from Phase I through life cycle management. Briefs senior management on assigned projects or studies as needed. Subject matter expert in multiple therapeutic areas.CRO / Vendor Oversight:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …providing forecasting & financial support to Brand Teams by assisting product directors/ managers with strategic planning and financial consulting, leading financial ... planning and net revenue forecasting processes.The person will own and facilitate the forecasting process to develop P&L projections for the inline and pipeline brands, partner with various functional groups to provide financial assessment, communicate results… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in ... support of benefit risk profile throughout product life cycle. Collaborates with the PSL(s) to proactively plan and prioritize safety surveillance and risk… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for assigned project(s).Strategize and plan for FDA meetings for assigned product . Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting ... breakthrough therapy designation requests, orphan drug applications.Participate in global product team meetings (development and marketed products); provide regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …experience with one or more clinical systems like CTMS, EDC, eTMF, Planisware, Product Registry, Regulatory etc. required4 or More Years Experience in working with ... CRO data for execution of large global clinical trials. requiredSolid understanding of Metrics, KPIs, KRIs and KQIs related to large scale global clinical trial end to end execution. preferredDemonstrated ability to influence at all senior organizational… 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 ... protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic and ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's global drug ... safety is diligently considered prior to selecting promising candidates (DP0), allowing product safety leaders (PSLs) and global project teams (GPTs) to enact a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Job Summary: The Global Brand Associate Director is accountable for supporting the development, integration, and execution of all ... for is provided to cross-functional teams including but not limited to product clinical development team(s), HEOR, PRA, medical affairs, manufacturing and PR. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oversees early-stage trials, such as global clinical development program for multiple product candidates with one or more indications; Interacts with our Discovery ... and Research programs for development of early clinical studies. Provides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position ... may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects of increased complexity including post marketing projects and those involving 3rd party development.… more
