- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop and execute ... oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will...manager oversight, the individual will lead global pricing strategy development , access strategy development and partner with… 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 ... assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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, ... mindset and culture through partnering with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies. Provide quality… 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 ... including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety...may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Project Teams including strategic development and execution of an integrated product development plan. This position may independently manage a lower ... of the clinical development plan in alignment with the product development strategy.Manages team meetings including developing agendas and documenting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global pharma innovator in oncology, a therapeutic area known for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and ... 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… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary Deliver the development and implementation of Research & Development (R&D) informatics systems ... global sites. These business functions include: Clinical Operations, Clinical Development , Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with minimal supervision. This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other ... under minimal supervision to solve complex project problems.Responsibilities- Protocol Development , Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation,… 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 ... consistent with CDP and aligned to achieve the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response… 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 ... 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)
- … development team. preferredKnowledge of design control, market and product requirements management, and the IVD development process preferredKnowledge ... Experience Qualifications7 or more years of relevant experience managing complex development projects required4 or more years of work experience in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure high quality compound and multi-compound level deliverablesLead the development of global harmonization of programming processes supporting global ... retaining, developing, and managing employeesGuide career growth and provide development opportunity for statistical programmersManages contract statistical programming staff… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development strategies for program/s under IST; Obtains cross-functional alignment ; Leads development and execution of Product Development Plan and ... and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key submission documents;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …based on customer insights, external landscape, and internal information including overall product development plans.- Proactive planning for asset milestones to ... plus emerging pipeline assets to advance our research and development . This role will lead workstreams with highly matrixed...critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead and core… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …industry, vendor base, and regulatory issues for respective categories. Leads the development of sourcing strategy for respective categories. Builds and maintains a ... vendor base. Manages vendor relationships. Implement sourcing and value development roadmap and initiatives; contribute to strong supplier relationship management,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including (mAb, Drug Substance, Drug Product , or New Modality) process and product development preferred Travel Ability to travel up to 30%. Global and ... diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product , or New Modality) Lead is responsible for the management of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …4 or More Years Extensive experience in project management, process, product , and/or analytical development activities and pharmaceutical/oncology project ... defined based on the project needs and the respective development stage of the project. The CMC Lead will...transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes supporting global ... developing, and managing employees. Guide career growth and provide development opportunity for statistical programmers. Manages contract statistical programming… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities.SummaryThis position supports early phase oncology development and leads complex studies in study design, statistical analysis ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder minimal guidance of the Senior Director or Director , Business Development Execution, the primary function includes coordinating various ... and maintenance of regulatory activities associated with assigned Company Business Development (BD) Agreements.- These agreements include but are not limited to… more
