Daiichi Sankyo, Inc. Jobs

AI Summary

The Senior Clinical Study Manager at Daiichi Sankyo will lead clinical study execution, ensuring adherence to Good Clinical Practices, SOPs, and regulations. Responsibilities include developing study plans, managing cross-functional teams, overseeing CRO and vendor activities, monitoring study performance, and ensuring budget compliance. The role requires strong communication, decision-making, and project management skills, along with a focus on delivering quality and timely study deliverables.

AI Summary

This operational role supports project objectives by managing vendor interactions, packaging design, and patient kit supply, ensuring compliance with global regulatory standards. It requires expertise in GMPs, GCPs, and IRT systems with a focus on clinical supply management and drug dispensing control.

AI Summary

The Manager, Data Programmer supports Data Management and Biostatistics by performing programming tasks, including SAS programming and validation, managing external vendors, ensuring high-quality deliverables, and developing reports for clinical trials. The role involves creating and maintaining CDISC SDTM specifications, mentoring associates, and ensuring compliance with SOPs and industry standards, while contributing to innovation in reporting systems.

AI Summary

The Director of Clinical Development provides medical accountability and oversight for clinical trials, manages Phase 1-3 studies, and offers scientific expertise to colleagues. Responsibilities include medical monitoring, protocol development, and clinical data interpretation. This role involves collaboration with global teams, addressing regulatory questions, and leading clinical development strategies to advance innovative pharmaceutical therapies.

AI Summary

Support Global and Regional Quality Leads in delivering and executing R&D QA strategies and activities. Collaborate with stakeholders to ensure compliance, manage CAPAs, participate in audits, and drive continuous improvement in quality standards and processes.

AI Summary

The Project Manager (RACMC) leads complex filing activities, ensures compliance with regulatory standards, and manages resources efficiently. Responsibilities include coordinating global regulatory dossier submissions, managing risks, and implementing process improvements. The role requires collaboration with internal stakeholders, conducting regular project meetings, and maintaining IT tools and knowledge sites.

AI Summary

The intern will develop programming tools and create data visualization and summary tables using R/R Shiny. This role offers training in statistical programming within a pharmaceutical company and supports programming activities under supervision, contributing to department initiatives.

AI Summary

The intern will engage in statistical programming, focusing on developing programming tools like macros and apps. The role involves using SAS for data visualization and summary tables, supporting basic programming activities under supervision. Ideal candidates are detail-oriented, proficient in SAS, R/R Shiny, or Python, and possess strong communication skills.

AI Summary

Lead statistical activities for complex studies, including study design, protocol development, and results interpretation. Collaborate with study teams and CROs, ensuring high-quality data. Contribute to drug development plans and global health authority documents, guiding CRO programmers and statisticians.

AI Summary

This role involves developing global Clinical Study Start-Up strategies for PV Safety Operations, overseeing SAE Flow Plans, managing EDC Safety report outputs, and ensuring compliance in clinical study safety reporting. The position requires strong organizational and interpersonal skills, representing PV Operations at study meetings, assisting in process improvements, and collaborating with global study teams and CSPV. Responsibilities include establishing EDC standards and managing safety documentation to ensure quality and compliance.