- Daiichi Sankyo, Inc. (Bernards, NJ)
- …multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical Operations on ... the associated budget meet the needs of the overall development plan agreed to by the Global Project Team...their therapeutic area. Management requires review of resources against development pipeline to identify areas of resource gaps or… more
- Merck & Co. (Rahway, NJ)
- …other Directors and/or Senior Directors responsible for Atherosclerosis clinical development projectsThe Executive Director may supervise the activities ... in their area of responsibility.To accomplish these goals, the Executive Director may:Author and/or oversee detailed development documents, presentations,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... by collaborating with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV QA) ensures high ... process improvements. Collaborating with the Global QMS eCompliance team, the director oversees QA plans, promotes data governance, and engages stakeholders to… 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 ... areas centered around rare diseases and immune disorders. Summary:The Associate Director , Oncology Value & Market Dynamics Training Manager is responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross functional GxP areas in the DS groupResponsible for the development of cross-functional training strategies Strategic roadmap including , infrastructure, ... programs, and document/record management principlesResponsible for the development of document and record management principles for Global GxP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision and ... and execution through RBQM activities. Accountable for the management, performance, and development , both technical and career, of direct reports, and mentors or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance ... the value of our oncology pharmaceutical products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end delivery of ... to ensure high quality of laboratory data deliverables to support drug development processes and global submissions. This position provides leadership within Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable ... quality standards. This position reports to the Head, Global Development and Medical Affairs QA RDPVQA, and oversees multiple...with Japan. This individual is a member of the Development and Medical Affairs QA leadership team and maybe… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development ... patients treated within the oncology compounds throughout the course of clinical development through the commercial setting. In this role, the incumbent will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position is responsible for performance of the function and the development of group members. This position also monitors trends in functional performance ... sufficient understanding of regulations and GCP requirements for drug development , advanced knowledge of Electronic Data Capture/related applications and industry… 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 Dose Preparation ... experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development or technical writing required1 or More Years experience in… more
- Merck & Co. (Rahway, NJ)
- … development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible ... portfolio of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant area.ResponsibilitiesResponsible for the design, configuration, customizing and further development of the relevant SAP SuccessFactors modules with a ... holistic e2e process perspective including the use of other tools as necessary and ensuring the connection and data flow with adjacent modules or other external process steps where appropriate.Ensure and execute smooth operations and technical support of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …some complexity. This position makes decisions with consultation. Responsibilities:Planning for Development : Manages multiple CMC development projects. Leads ... submission teams with supervision. Acts as point of contact to cross-functional teams on US/EU RA CMC project issues.Execution of Strategy and Submissions: Develops strategy with supervision. Prepares content templates and leads technical team in preparation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Head of Center of Excellence (CoE), Global Medical Safety will ... complex issues across the DS portfolio, including both compounds in clinical development and marketed products. The successful candidate will work in collaboration… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The primary responsibilities of this position are to assist in the development and implementation of companion diagnostics (CDx) strategy in support of projects ... Global Project Teams within Daiichi Sankyo's Early and Late-Stage Development Portfolio. The individual will play a key role...CDx portfolio leader, covering all areas from CDx assay development through CDx approval and launch. May act as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …organization. This position will report to the Global Head of Late-Stage Oncology Development . This individual will play a central role in supporting the Global Head ... of Late-Stage Oncology Development in the formation and management of the newly...lead initiatives intended to expand the Daiichi Sankyo global development footprint or to promote globalization. The incumbent will… more
