- 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)
- …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 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)
- …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)
- …processes supporting global submission. Responsibilities - Statistical Programming Management : Coordinates outsourced statistical programming of analysis data sets ... deliverables at reasonable cost. Identify/develop tools for efficient vendor management . - Global Health Authority Interaction / Negotiation: Reviews documents… 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)
- …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)
- …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 may independently manage a lower complexity or regional project or be partnered… 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)
- …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)
- …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)
- …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)
- …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)
- …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)
- …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)
- …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)
- …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)
- …perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior ... MW for the CSR; Working with Clinical Safety Pharmacovigilance (CSPV), defines product level surveillance plan and interpretations, eg language for IB; Documents… more
- Merck & Co. (Rahway, NJ)
- …requires a talented and strategic leader to head the Strategy and Portfolio Management Team with responsibility for expanding the product portfolio, including ... by telling the broader solution story and conducting competitive analysis.New Product Introduction (NPI) Management :Manage NPI portfolio planningProvide NPI… more
