Ready to have an impact? Sumitomo Dainippon Pharma Oncology, Inc. (SDP Oncology) is hiring for the following positions.
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Director of Forecasting
The role of Director of Forecasting is to manage the design and execution of global forecasting capabilities to support decision making and strategy development for oncology assets in all phases of development (pre-clinical, phase I – III) and Business Development opportunities. Responsibilities also include planning and management for in-line brand forecasts, tracking performance, and presenting insights to cross-functional teams and senior management.
AD/Director, Statistical Programmer
This professional will function as the lead for statistical programming process improvement, CDISC SDTM/ADaM data standardization. He/she will enforce the appropriate standards in the department and provide training. Other responsibilities include 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.
Executive Director of Biostatistics
The Executive Director of Biostatistics will oversee the biostatistics team activities at Sumitomo Dainippon Pharma Oncology (SDP Oncology). This role will be a key member in the leadership team of Data Science Department and will lead and optimize the application of statistical science into drug development in collaborations with Research and Development partners.
Executive Director Regulatory CMC
The Executive Director, CMC Regulatory Affairs, will be responsible for and providing leadership in all Regulatory Affairs functions relating to Technical, Manufacturing and Quality Operations for development and marketed products. The position will involve writing, reviewing and filing regulatory submissions and have a key role in relevant communications and meetings with Regulatory Authorities.
Manager, R&D IT
The Manager, R&D IT will work closely with IT and members of the Research and Development organization to identify and deliver technology solutions that meet current and future needs of the organization. This role requires strong business analysis and collaboration skills, and a deep knowledge of business process and applications within Life Science’s Research and Development, primarily Quality Assurance, Regulatory Affairs/Operations and Pharmacovigilance. This individual will work closely with R&D leadership to understand business goals, objectives and operations, and develop IT strategy to meet the needs of the business. This role will collaborate with solution vendors, SDP IT Infrastructure and SDP Quality Assurance as necessary for implementation and other services.
Medical Director, Drug Safety and Pharmacovigilance
The Medical Director will provide hands-on PV support for Sumitomo Dainippon Pharma Oncology’s investigational and commercial stage Oncology products. Responsibilities include routine PV surveillance, data assessment for aggregate safety reporting, and maintenance of the benefit/risk profile in a cross-functional team environment. There will be opportunities to provide PV subject matter expertise to clinical development activities such as updating program clinical study documents (e.g., protocols and Investigator’s Brochures) and writing Clinical Study Reports. Additionally, this person will be responsible for performance of Medical Review with support from an external partner.
Principal, Statistical Programmer
• 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 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.
Senior Clinical Data Manager/Associate Director, Clinical Data Management
The Senior Clinical Data Manager/Associate Director, Clinical Data Management assists the Senior Director, Clinical Data Management with data management activities in support of Sumitomo Dainippon Pharma 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 complete data. Additionally, the incumbent impacts multiple clinical development programs, health authority submissions, presentations, and publications across internal and external stakeholders.
Senior Medical Director, Translational Medicine-Oncology
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.
Senior Administrative Assistant
Provide administrative support to the Chief of Staff and other designated executives including CEO & Global Head of Oncology, Global Head of Development & CMO, and Global Head of Corporate Strategy & Planning.
Senior Financial Analyst
The Senior Financial Analyst on the Planning and Analysis team provides integral business partnership support to the functional departments, finance, and leadership team to execute the financial planning, forecasting, reporting and analysis process. This role facilitates financial reporting and analysis for Sumitomo Dainippon Pharma Oncology’s leadership team, assists in the preparation of financial plans and forecasts based on the Company’s strategy, and performs financial analysis and scenarios using appropriate financial concepts and techniques.
Vice President, Head of Translational Medicine and Early Development
The Head of Translational Medicine and Early Development will develop and execute translational medicine and early development strategy to effectively bridge preclinical and early clinical phases to improve overall success/speed of portfolio assets.