- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders. Summary This 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)
- …pharma/diagnostic development team. preferredKnowledge of design control, market and product requirements management , and the IVD development process ... milestones and goals to the project team, department leadership, and senior management .Ensure project documents are complete, current, and available in a centralized… 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)
- …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)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for developing the Global ... of the activities in the GMA plan including Launch Readiness and Life Cycle Management for the assigned compound and will report into the Global Oncology Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Director , Global Oncology Marketing (Brand) is responsible for maximizing the commercial ... indication(s)/tumor(s):- Represent and provide input as an active part of the Global Product Team- Provide commercial insights to RD for new opportunities to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …programming processes supporting global submission.Responsibilities- Statistical Programming Management : Coordinates outsourced statistical programming of analysis ... deliverables at reasonable cost. Identify/develop tools for efficient vendor management .- Global Health Authority Interaction / Negotiation: Reviews documents and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …simultaneously. preferred- 4 or More Years Extensive experience in project management , process, product , and/or analytical development activities and ... to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions to meet smooth… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support ... of epidemiologic studies, including real-word evidence (RWE), supporting senior management in various epidemiological activities.This position independently carries out… 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 ... on customer insights, external landscape, and internal information including overall product development plans. - Proactive planning for asset milestones to account… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior ... (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… more
- 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 ... for the assigned oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will be responsible for providing… 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)
- …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 ... on customer insights, external landscape, and internal information including overall product development plans.- Proactive planning for asset milestones to account… 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)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... drug products consistent with the company goals; specifically, for the life-cycle management of NDAs/BLAs. This individual will be responsible for working on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …GCP strategic discussions.Support the Head of RD QA with Quality Reviews of respective product profile to ensure appropriate management review of all quality and ... Within assigned GPTs, facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and submission… 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
- Merck & Co. (Rahway, NJ)
- …activities supporting the production of clinical supplies with focus on drug product . Additionally, experience in medical device and/or combination products would be ... and develop a strong working relationship with commercial external quality management personnel.- The incumbents would be the key quality representatives attending… more
- Merck & Co. (Rahway, NJ)
- …strategic counselor to support pneumococcal and pediatric communications and issues management , in coordination with Director , Global Vaccines Communications. ... Product communications experience; preferably within vaccines. Strong project management skills with proven success managing and executing major projects.… more
