- Daiichi Sankyo, Inc. (Bernards, NJ)
- …member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other ... the CSPV on the Global Product Team or specific sub-teams such as clinical study team and submission team, providing the safety leadership and serving as the… more
- 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)
- …critical support to the CSL and Medical Monitor in the execution of Clinical Development functions. Responsibilities: Study 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)
- …SummaryThis position oversees and manages US Medical Affairs activities including strategy , communications, and medical affairs directed clinical activities ... or Commercial Brand Teams, the Medical Affairs lead develops the medical/commercial strategy based on the scientific development and appropriate communication… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …multiple direct reports. Responsibilities:Operational Strategy :Align with the Head of Clinical Development Operations or Senior Director, Clinical ... successful execution of all operational components of a large-scale global clinical program using strong clinical...compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy : Provides the strategic ... 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)
- …member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other ... , clinical pharmacology, and/or epidemiology required.Must have expertise in global clinical safetyDaiichi Sankyo, Inc. is an equal opportunity/affirmative… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in accordance with DS standards. The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd Party Vendor Management and ... accountability for operational study level time, cost and quality deliverables.Lead the development of the clinical study plan including critical path activities… 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)
- …Degree requiredMaster's Degree preferred Experience: Minimum of 5 years of Global Clinical Trial experience in the device/pharmaceutical/CRO industry ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...application of external data vendor access standards across DS clinical programs. Participate in the development of… more
- Merck & Co. (Rahway, NJ)
- …drive alignment with the goals, purpose and mission of our Company's Research Labs, Global Clinical Development (GCD) and GCTOPositive proven success in ... development of their country /-cluster to deliver clinical trials as per global clinical...Areas, and when appropriate Human Health.-Working with regional and global colleagues develops and executes the GCTO strategy… more
- Merck & Co. (Rahway, NJ)
- …Scientist (Executive Director) and Product Development Team (PDT) lead, Oncology Global Clinical Development , has primary responsibility for the planning ... will manage the entire cycle of clinical development , including development strategy , study...lead may:-Manage Directors and/or Senior Directors responsible for Oncology Global Clinical Development projects.-Supervise the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full of ... globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full ... globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the… 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)
- …function by collaborating with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data ... portfolio milestones, and/or initiatives to achieve/exceed departmental quality/time/cost objectives.Leads development and implementation of DM reporting strategy … 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …independently and can contribute to remediation plansCompetent knowledge of pharmacology, clinical research and medical terminology, global data entry ... 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)
- …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
- Merck & Co. (Rahway, NJ)
- …precedence and competitive intelligence to facilitate development of regulatory strategy .- Assist the global regulatory lead in authoring of regulatory ... a global regulatory lead(s) to help develop and implement a global strategy for registration and/or maintenance of products.- Responsibilities may encompass… more
