- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary This position is responsible for providing project management, drug development expertise to Global Project Teams including strategic development ... Team leader as the Project Management lead on drug development projects. This position can be assigned to any...these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …members engaging in external innovation. This will range from working with GBD leadership and HR Training and Development to identify the core competencies ... care across a range of cancers, the Global Business Development (GBD) organization is evolving to meet the needs...company. The Global External Innovation organization plays a key leadership role in the twin pillars of this evolution:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- Project Planning and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase I-III clinical ... Budget Planning - Manages and is accountable for the development and control of functional budget in support of...and decisions aligned with organizational strategies and objectives.- People Leadership - May lead small team; Coach, motivate and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …current academic, clinical trial and practice issues related to DS Oncology development and therapeutic strategies.- Partner with the commercial teams to oversee and ... portfolio serve as the US Medical Affairs lead or Global lead in development committees and global medical affairs activities. Represent Medical Affairs in new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study safety reporting and activities.Global Management Strategy and Goals and Procedure Development : Assist Leadership to ensure compliance with protocol and ... rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and ... management. Review contribute to revision of DSI contracts (eg development , license, distribution agreements)Manage, negotiate, and revise collaborative license… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Business Relationship Managers (BRM) for corporate functions globally.Responsibilities- Leadership : Provide leadership /direction, management and guidance for ... of Business Relationship Manager (BRM) for corporate functions to foster development and growthStrategic partnership with key senior leaders and decision makers:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary Responsible for managing the design, development , optimization and administration of global HCM Platforms and processes. This ... as a liaison between the customer community and the software development team, documenting functional, system, and process requirements.Possess a blended… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …improvements in the operational efficiency of PJ Lead and Tech Unit.- Provides leadership in the project/ development team, as Matrix Lead, interfacing with ... defined based on the project needs and the respective development stage of the project. The CMC Lead will...Responsibilities - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads ... 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. (Bernards, NJ)
- …and technical feasibility and delivery. The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead must ... include but are not limited to Clinical Operations, Clinical Development , Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(GPT) as an ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads ... Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and maintenance of the CCDS, US and EU labeling, and manages… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(GPT) as an ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads ... Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and maintenance of the CCDS, US and EU labeling, and manages… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …external policies, standards, and processes for vendor interactionServe as the leadership -level point of contact between the vendor organization and internal ... & ManagementOversight of Data Request processing by Service ProvidersTraining and development of Service Provider resourcesFacilitates and participates in vendor and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary: This role is responsible for providing regulatory strategic and tactical leadership , and alignment to ways of working on assets which are subject ... implement effective regulatory strategies to deliver on efficient and robust development plans. The individual will direct, coordinate and implement the preparation… more
- Merck & Co. (Rahway, NJ)
- …marketed Oncology medicines. Our Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire ... in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and Assist the Senior/Executive Director /AVP in… more
- Merck & Co. (Rahway, NJ)
- …and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and ... GMP and compliance mindset and collaboration with various partners and stakeholders in development .The Director will report to the Executive Director of… more
- Merck & Co. (Rahway, NJ)
- …development , with a strong, integrated understanding of the strategic elements of drug development . As a subject matter expert, the Director within the QP2-IO ... for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. Directors demonstrate outstanding leadership… more
- Merck & Co. (Rahway, NJ)
- …with proven track record of contribution to medical or clinical development strategiesCustomer expertise, especially of scientific leadership and other ... Job DescriptionThe Executive Director , Value & Implementation (V&I), Global Medical and...Medical and Scientific Affairs (GMSA) is accountable for the development and execution of scientific & medical affairs plans… more
- Merck & Co. (Rahway, NJ)
- … development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible ... for providing strategic and technical leadership for analytical development of candidates from...of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50… more
