Ready to have an impact? Sumitomo Dainippon Pharma Oncology, Inc. (SDP Oncology) is hiring for the following positions.
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Associate Director, Statistical Programmingfeature_careers_department_development
Function as a lead for statistical programming process improvement, CDISC SDTM/ADaM data standardization. Enforce the appropriate standards in the department and provide training. Responsible for planning and tracking the statistical programming activities such as designing, developing, validating, updating, and documenting SAS programs to generate analysis datasets, data listings, summary tables, and statistical graphs supporting safety and efficacy analyses.
Associate Director, Data Design and Systemsfeature_careers_department_development
The Associate Director, Data Design and System assists the Senior Director, Data Science Excellence and Innovation with clinical data captured system design, setup and maintains in support of SDP Oncology studies across all stages of clinical drug development. The incumbent ensures that clinical data capture, systems, and processes represent accurate, consistent, high quality, and reliable data capture, storage and sharing. Additionally, the incumbent impacts multiple clinical development programs, health authority submissions, presentations, and publications across internal and external stakeholders.
Director/Senior Director, Regulatory Affairs CMCfeature_careers_department_development
The Director/Senior Director, Regulatory Affairs CMC will act as a CMC regulatory representative to develop CMC regulatory strategies, submissions and compliance activities.
Executive VP, CMO and Global Head of Developmentfeature_careers_department_development
The EVP & CMO is the chief architect of the clinical development and product registration road maps, bridging basic science with clinical science, setting the development and regulatory strategy. The CMO will lead, manage, and direct the Company’s discovery and clinical development programs, medical science, and regulatory affairs registration pathways. The CMO provides leadership, strategic insight, and operational expertise for the Company’s research, development, medical and regulatory affairs functions.
Principal/Associate Director Biostatisticsfeature_careers_department_development
The Principal/Associate Director of Biostatistics will be a key member of one or more clinical project teams who will be responsible for statistical aspects of clinical development of the studies in one or more clinical project teams. Specifically, he or she will be responsible for the statistical decision making, innovative statistical design, modeling and simulation, and external collaborations on project level.
Senior Manager – PV Operations & Sciencesfeature_careers_department_development
Senior Manager, PV is a dual role as Pharmacovigilance (PV) Scientist and a PV Operations Study lead within Sumitomo Dainippon Pharma (SDP) Oncology Drug Safety & Pharmacovigilance department. In this exciting and challenging role, you will work with the Program Safety Lead, PV Operations, other PV Scientists and PV Physicians, as well as cross-functional teams. This role will be a leader in managing and performing PV Operational and Scientist activities for assigned drug programs.
Senior Medical Director, Translational Medicine-Oncologyfeature_careers_department_development
The Senior Medical Director will lead the direction, planning, execution, and interpretation of clinical trials activities of novel compounds, in various indications through early development to global regulatory submissions.