Ready to have an impact? Sumitomo Dainippon Pharma Oncology, Inc. (SDP Oncology) is hiring for the following positions.
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Clinical Trial Associatefeature_careers_department_development
The Clinical Trial Associate (CTA) is responsible for supporting the conduct of clinical trials and handling administrative aspects of clinical trial execution. This role will support completion of all study deliverables, ensuring the highest level of data quality; proactively identifies, communicates, and resolves clinical study operational issues; and participates in process improvement initiatives as required.
Clinical Operations Regulatory Specialistfeature_careers_department_development
The Clinical Operations Regulatory Specialist will be responsible for ensuring that SDP Oncology studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections according to Veeva processes. Ensure accountable functions are in compliance with the requirements of the TMF SOP and Veeva work instructions. Support, consult and provide TMF guidance to staff during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF.
Clinical Project Managerfeature_careers_department_development
The Clinical Project Manager is responsible for the planning, implementation, execution and management of multiple clinical studies by overseeing day-to-day operations and directly manage outside Clinical Research Organizations.
(Senior) Associate, Clinical Qualityfeature_careers_department_development
This position is responsible for supporting quality and compliance in good clinical practices and oversight of SDP Oncology’s clinical trials with drug products including small molecules, peptides, and drug delivery devices. This role includes interactions with Clinical Research Organizations (CROs), local and central clinical testing laboratories, biomarker research and diagnostics laboratories, and principal investigator sites. This individual should have an interest in GCP and be highly motivated to learn.
Director/Senior Director, Financial Planning & Analysisfeature_careers_department_general
The Director/Senior Director, Financial Planning & Analysis will be responsible for leading the management and oversight of financial planning and operational finance. This includes company-wide Financial Planning and Analysis process, including annual budget and quarterly financial forecasts. Proven track record of being a strong cross-functional collaborator, an outstanding communicator, and a nimble, innovative, and strategic thinker. This individual will be an inspiring leader that can further develop a team of finance professionals who are looking to enhance their growth and make an impact.
Director/Sr Director, Regulatory Affairs CMCfeature_careers_department_development
The 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.
Research Scientist I, Translational Biologyfeature_careers_department_research
The Research Scientist will work in our Translational Biology lab and will be part of the Translational Biology team. The position is focused primarily on the Company’s in vitro and in vivo preclinical research efforts. He or she will be responsible to perform all duties related to experimental design and execution, data analysis, presentation of laboratory results, general laboratory responsibilities and assisting colleagues and/or mentoring interns. He or she must be self-motivated, independent, detail-oriented, collaborative, and willing to take risks.
Senior Clinical Operations Regulatory Specialistfeature_careers_department_development
The Senior Clinical Operations Regulatory Specialist will be responsible for ensuring that SDP Oncology studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections according to Veeva processes. Ensure accountable functions are in compliance with the requirements of the TMF SOP and Veeva work instructions. Support, consult and provide TMF guidance to staff during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF.
Senior Manager, CMC Project Managementfeature_careers_department_development
The Senior Manager, CMC Project Management will function as a Project Manager for the CMC programs in early development. He or she will work closely with external CMO and internal cross-functional teams to advance the assigned programs in the development portfolio.