- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Job Summary: The Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the ... medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global ... Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads… more
- Merck & Co. (Rahway, NJ)
- …(QP2-IO) - team in the role of Director . QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development ... development , with a strong, integrated understanding of the strategic elements of drug development . As a subject matter expert, the Director within the QP2-IO… more
- Merck & Co. (Rahway, NJ)
- …team in the role of Associate Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development ... communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with...Serving as an expert representative for QP2-IO on Oncology clinical development teams. Framing critical questions for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross- functionally and in global teams.Strong Industry Network in clinical development . Knowledge and understanding of cultural differences and diversity ... centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity ( Global R&D...Set the strategic direction to define best approach for clinical development systems, PV systems and MA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of managing multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , ... successful execution of all operational components of a large-scale global clinical program using strong clinical...the associated budget meet the needs of the overall development plan agreed to by the Global … more
- Merck & Co. (Rahway, NJ)
- …and patients leveraging digital, data and analytics and measuring the impact. The Director of Global Commercial Pipeline Analytics will be responsible for ... Job DescriptionDirector, Vaccines Global Commercial Pipeline Analytics, HHDDAOur Human Health Digital Data and Analytics (HHDDA) team is innovating how we understand… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data, demographic/representativeness of samples from clinical trial and screen failures. Clinical trial protocol development and reviews ( clinical trial ... Global Regulatory Strategy in the Drug and Device Development and Commercialization process.Experience with developing and documenting regulatory strategies in… more
- Merck & Co. (New York, NY)
- …enrollment and retention efforts to achieve study milestones. Upon request from Global Clinical Trial Operations (GCTO). Recommends study sites and identifies ... potential investigators to participate in phase II-IV clinical development programs, conducts Site Initiation Visits (SIVs), and detects barriers to patient… 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
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number ... technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the necessary information to author the ... 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development or technical writing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project ... 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 ... research areas centered around rare diseases and immune disorders.SummaryThe Director , Clinical Safety, will be a product...Global Product Team or specific sub-teams such as clinical study team and submission team, providing the safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …guidance on complex issues across the DS portfolio, including both compounds in clinical development and marketed products. The successful candidate will work in ... areas for translational medical safety and make a meaningful impact on clinical development at the program level.Lead projects to enhance processes… more
- Merck & Co. (Rahway, NJ)
- …final approval for all submissions and associated documentation. Provide expertise as the Global Regulatory Lead to Product Development Teams and the regulatory ... single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS)...agencies for multiple indications simultaneouslyProvide expert advice as the Global Regulatory Lead to Product Development Teams… more
- Merck & Co. (Rahway, NJ)
- …and Pharmacometrics (QP2) department drive model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/ development ... at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate Director … more
- Merck & Co. (Rahway, NJ)
- …HTA submissions. The incumbent is expected to work cross-functionally with clinical development , medical affairs, biostatistics, market access, commercial and ... work.-Develops American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value DossiersDevelops supplementary clinical data package in close… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and standards. This position ensures quality delivery of laboratory data for clinical trials, clinical development , and regulatory submissions. This ... company-wide laboratory data management strategies and processes in support of clinical development objectives.- Accountable for lab data management deliverables… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …evolution and implementation of training curriculum and workshops. In addition, the Associate Director will be involved in the development /training of field ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …US Operations, including but not limited to - Commercial, Patient Services, CMR ( Clinical , Medical, Regulatory), Finance, and Novo Nordisk global colleagues, to ... Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent,… more
