- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical history, and medications when needed Clinical Development Expertise Strategy :In collaboration with the Global Clinical Lead (GCL), if ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...from a medical strategy standpoint to the development of clinical sections of study-level documents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of commercialization.- For Oncology portfolio serve as the US Medical Affairs lead or Global lead in development committees and global medical affairs ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …critical support to the CSL and Medical Monitor in the execution of Clinical Development functions. ResponsibilitiesStudy Strategy : Drafts development ... of study design to meet study objectives, development of biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position works with the Director, Clinical Study Startup to establish the strategy driving global Clinical Study Start-Up activities for PV Safety ... and compliance across clinical study safety reporting and activities. Global Management Strategy and Goals and Procedure Development : Assist Leadership to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Executive Director, US Head GPM&L. ResponsibilitiesProject Responsibilities: Independently manage or lead strategy development on Global Project Teams (GPT) ... with the Global Team Leader in driving strategy development and ensures the execution of...drive the development and delivery of the clinical development plan in alignment with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy : Provides the strategic ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …learning cross functional roles and responsibilities such as (but not limited to) Clinical Development , Global Medical Affairs, Biostatistics, Clinical ... zones such as Japan. Education/Experience: o Express an interest in Leadership and Global Research and Development Drug Processes. Prior experience in project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... support of new and approved drug products.Seeks and incorporate regional and functional RA strategy into a global strategy .Responsible for ensuring aligned … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global sites. These business functions include but are not limited to Clinical Operations, Clinical Development , Biostatistics and Data Management, ... and technical feasibility and delivery. The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relationships with key stakeholders within CSPV and external functions including Clinical Development , Research Development , Regulatory Affairs. Facilitate ... research areas centered around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross-functional Medical Safety collaborations within and across line functions, eg Clinical Development , Medical Affairs, Regulatory Affairs, Clinical ... around rare diseases and immune disorders. Job SummaryThe position develops the global safety strategy , oversees risk management activities, and recruits and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including dictionary support documentation. Collaborates cross-functionally with the Medical, Clinical Development , Clinical Scientists, Clinical ... to ensure high quality coding deliverables are on time to support drug development processes and global submissions. This position also partners with internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …field of oncology, with a deep understanding of the drug discovery and development process, clinical trials, and regulatory requirements. TravelAbility to travel ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...Daiichi Sankyo, and where applicable, partner companies for the development and approval of US, EU and global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analysis.Responsibilities:Project Planning and Forecasting - Manage and is accountable for the development of Clinical Project Budget templates in support of ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...early phase to late-stage clinical studies. Accountable for the control and reporting of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...Daiichi Sankyo, and where applicable, partner companies for the development and approval of US, EU and global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in meeting or teleconferences with Health Authorities- Global BDO Strategy to Improve Drug Development : Primarily participates and may occasionally ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...with data manager to ensure high quality data.- Drug Development Strategy : Provides input to multiple aspects… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... and natural killer (NK) cell-based immunotherapy.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of… more
- Sanofi Group (Bridgewater, NJ)
- ** Global Clinical Development Strategy Expert - Vaccine** **Location: Waltham, MA** **Work model: Hybrid** **About the Job** We are an innovative ... Sanofi Vaccines R&D. + Have global responsibility and ownership for the Clinical Strategy , the respective Clinical Development Plans (CDP) and study… more
- Sanofi Group (Bridgewater, NJ)
- …and customer needs, while aligned with the overall global Sanofi digital strategy : + Translate clinical development functional strategies and operational ... **Job Title:** Global Head of Digital Clinical Development **Location:** Bridgewater, NJ **About...world. To ensure the success of Sanofi's Research and Development strategy , Digital Clinical … more
