- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated project/product risk management ... a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and serious breaches of GCP. The SDL is accountable for escalation to the OPL/Asset Lead (or Senior Line Leaders in the absence of Asset Lead ).-Where ... with different levels of study governance, as required-Oversee the development of the clinical study plan including...The SDL is accountable for escalation to the Asset Lead (or Senior Line Leaders in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reports are properly trained, following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead ) is fully informed of ... a coordinated and aligned strategy.Responsibilities:Operational Strategy and Oversight:Align with the Senior Director, Global Clinical Operations on plans for… more
- Eisai, Inc (Nutley, NJ)
- …provides strategic leadership for global outsourcing and vendor management activities within clinical development . This role is accountable for designing and ... Salary Transparency Language:The annual base salary range for the Senior Director, Clinical Outsourcing is from :$223,800-$293,800Under current… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …US and Global Brand Team, and US Product Team to inform clinical development , commercialization, market access, and other cross-functional strategic ... Cycle Management. Leads the team for this compound.Responsibilities- Responsible for the development of the USOMA strategy and medical objectives for the assigned… more
- Merck & Co. (Rahway, NJ)
- …support and influence clinical and commercial combination product development and launches.Principal Responsibilities: Lead and set direction for the ... with applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… more
- Eisai, Inc (Nutley, NJ)
- …Information plan for their assigned therapeutic area. Utilize scientific expertise to lead the development and maintenance of medical information resources for ... and oncology, with a strong emphasis on research and development . Our history includes the development of...your profile, we want to hear from you. The Senior Medical Information Manager is responsible for contributing to… more
- Merck & Co. (Rahway, NJ)
- …clinical drug development , GCP and ICH guidelines, and the clinical regulatory environmentDemonstrated ability to influence senior level stakeholders and ... clinical organization within Translational Medicine (TMed) is responsible for early clinical development of novel therapeutics, working in close collaboration… more
- Merck & Co. (Rahway, NJ)
- …experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projectsAssist the Senior Director, Associate ... , the Clinical Director will manage the entire cycle of clinical development , including determination of appropriate disease indications to pursue and… more
- Merck & Co. (Rahway, NJ)
- …assurance, analytical laboratories, manufacturing, production support area, clinical development .-Strong leadership skills with the ability to lead teams ... shift.-Required Skills: Accountability, Accountability, Adaptability, Audits Compliance, Biochemistry, Chemistry, Clinical Development , Communication, Data Analysis, Detail-Oriented, Deviation… more
- Merck & Co. (Rahway, NJ)
- …and provides biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical , Regulatory, ... disease area. Primary activities :Serves as statistical representative and lead in the cross-functional teams for the strategic planning... project as neededLead biostatistics in early or late clinical development planning to ensure that study… more
- Merck & Co. (Rahway, NJ)
- …organizations (as a lead GCS Planning program representative) such as clinical development , regulatory, quality and other supply chain areas to negotiate ... external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the Program CSPM designs… more
- Formation Bio (New York, NY)
- …an experienced and forward-thinking Senior Director of Toxicology to join our Development team. In this role, you will lead our toxicology efforts, ... will be a key member of the Formation Bio Development team.About the Role Build and lead ...and oversee the execution of toxicology studies to support clinical development and regulatory submissions Contribute toxicology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Senior Director/Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical ... affairs projects within a specific compound or indication.Responsibilities- Support GMA the development of the Global Medical Affairs strategy and execution of the… more
- Merck & Co. (Rahway, NJ)
- …our Company communications teams. Key Responsibilities Product Strategy & Roadmap Lead and manage IT applications supporting corporate communications, serving as the ... priorities as new insights and data emerge. Discovery & User Research Lead ongoing discovery activities (user research, interviews, surveys, usability testing) in… more
- Merck & Co. (Rahway, NJ)
- …and OT/IT systems that enable formulation, filling, and support activities for clinical and development sterile products. This position supports start-up ... Job DescriptionThe Senior Automation Specialist provides end-to-end automation and quality...& Experimentation) center, with a primary focus on sterile clinical manufacturing within Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations… more
- Eisai, Inc (Nutley, NJ)
- …3 years MSL experience in Oncology/Hematology.Strong broad-based scientific and pharmaceutical knowledge. Clinical trial development and drug launch experience is ... and oncology, with a strong emphasis on research and development . Our history includes the development of...and its hhc mission; b) provide key scientific and clinical information about Eisai's products; provide a conduit for… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionFrom its roots as a clinical development company, Formation Bio is harnessing the power of deep ... learning and artificial intelligence to break clinical development paradigms and transform how drugs...Why Join Us? Impact: Shape IP strategy as our senior legal leader for a portfolio of clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …objectives are aligned and embedded in evidence generation, medical strategy, and clinical development plans, where appropriate. Gains strategic and planning ... strategy across medical, RD, and enterprise partners to advance oncology objectives.- Lead the development of a global External Scientific Collaboration (ESC)… 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
