- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Director Data Product Management Job Description We are seeking a strong, highly energetic and collaborative ... to become the premier "Data First" commercial biopharma organization.In this Associate Director Data Product Management role, you will be part of the HHDDA… 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)
- …and immune disorders.SummaryThis position is responsible for providing project management , drug development expertise to Global Project Teams including strategic ... development and execution of an integrated product development plan. This position is accountable for partnering...partnering with the Global Team leader as the Project Management lead on drug development projects. This position can… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA). Develops ... activities in the USOMA plan including Launch Readiness and Life Cycle Management . Leads the team for this compound.Responsibilities- Responsible for the development… 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 product safety team, and be responsible for overall product safety strategy or specific areas of safety surveillance and risk management , and provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Job Summary:This position will be a member of the Risk Management Center of Excellence office who will help manage risk management ... Individual will provide strategic advice, teachings, and support related to risk management planning, risk management sciences, and risk management … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …early-stage programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety ... the PSL(s) to proactively plan and prioritize safety surveillance and risk management activities for assigned product (s), including resource planning, oversees… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …RD Line Functions for promotion of Metrics and Dashboards strategy.Team Management Manage the Metrics Business Analyst Team Qualifications: Successful candidates ... experience with one or more clinical systems like CTMS, EDC, eTMF, Planisware, Product Registry, Regulatory etc. required4 or More Years Experience in working with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director , Privacy & Compliance Investigations, is a member of the Compliance ... protection and privacy laws, utilizing various elements of DSI's Privacy management program elements (eg policies, guideline, standards, tools, procedures, self-help… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the lead as the Head of PV QA with Quality Reviews of respective product profile to ensure appropriate management review of all quality and compliance ... research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product , or New Modality) Lead ... is responsible for the management of technology transfer of the manufacturing processes of...of the manufacturing processes of (mAb, Drug Substance, Drug Product , or New Modality) for investigational and commercial drugs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …plans for specific categories under the direction of the head of category management , for the creation, execution, tracking of strategies. Includes working under a ... in managing multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in leading complex initiatives of… 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 ... strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO, as needed; Accountable for clinical development plans, protocol… 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 ... functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as… 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...through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as… 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 medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1 -… 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 ... portfolio from the Research stage to post marketing/lifecycle management . Our expectation is that the person filling this role will pioneer and eventually lead a new… 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 ... all pre-launch and launch activities, counter-competitive strategic development, budget management , forecasting as well as coordinating commercialization activities with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … management relationship and governance. Responsible for Strategic Application product roadmaps to meet business objectives.Work with User Support Leads and ... functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …processes supporting global submissionResponsibilities - Statistical Programming Management : Coordinates outsourced statistical programming of analysis data ... quality deliverables at reasonable costIdentify/develop tools for efficient vendor management - Global Health Authority Interaction / Negotiation: Reviews documents… more
