Sr. Manager, Clinical Research Scientist
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our "People first" approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us.
Hybrid Employee Value Proposition: At Taiho Oncology, we are dedicated to transforming the landscape of cancer treatment and improving patients' lives. As a Senior Manager, Clinical Research Scientist, you will play a pivotal role in our mission, leveraging your expertise to drive innovative clinical research and contribute to groundbreaking therapies. We offer a collaborative and inclusive work environment where your ideas and contributions are valued. Join us to advance your career, work with passionate and skilled professionals, and make a meaningful impact on the fight against cancer. At Taiho Oncology, you will find purpose, growth, and the opportunity to be at the forefront of cancer research. Position Summary: The Senior Manager, Clinical Research Scientist has responsibility assisting in design, execution and reporting of current and future clinical oncology trials ranging from phase 1 - 3. Additionally, this role position supports the responsible medical monitor in the execution of key tasks involved in the design, conduct, monitoring and review of study data, analysis and reporting of clinical trials. Performance Objectives:- Collaborates with other key team members (Medical monitor, Project Manager, Clinical Operations, Data Management, Biostatistics, PV, PK, Biomarkers and Medical Writing etc.), to deliver high quality clinical trial results.
- Use scientific expertise to support the creation of relevant high-quality clinical documents such as study protocols and clinical study reports (CSRs), investigator brochures, DSUR, NDA/MAA registration documents and publications.
- Reviews and summarizes ongoing clinical data (from EDC and listings) to monitor the quality of the study, ensure clean data flow into the study database and compliance with the protocol.
- Keeps the latest knowledge in clinical development through publications and scientific conferences and leverages the knowledge for designing and summarizing clinical studies.
- Keeps Sr. Medical Director current on status of clinical trials and provides ongoing risk assessments for the study conduct and operational risks.
- Performs other duties as required.
- Masters level degree in pharmaceutical or related medical science is preferred. Bachelor's level candidates with substantive prior pharmaceutical experience will also be considered.
- 3-5 years of experience in clinical drug development in pharmaceutical industry.
- At least 2 years in drug development industry in oncology and with previous exposure to clinical development, such as reviewing of the quality of ongoing and final clinical study data, protocols and CSRs, investigator brochures, DSUR, NDA/MAA registration documents and publications.
- Ability to critically review and interpret Clinical data.
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