Taiho Oncology, Inc.
Job Description
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, the compassion we practice for our patients extends to our team, empowering and motivating them to do their best work for those who need it most. This is an exciting opportunity to lead global clinical trials and experience multiple facets of Clinical Development in a dynamic, supportive, collaborative, and global cross-functional environment. Position Summary This position has direct responsibility for design, execution and reporting of current and future clinical oncology trials ranging from phase 1 – 3. Performance Objectives Assumes the medical leadership on clinical trials for Taiho Oncology, Inc. (TOI) in the USA and Europe. This position serves as a responsible medical monitor or a Lead medical monitor for various clinical phase 1 - 3 trials, as needed. Uses medical/scientific expertise to create or support the creation of relevant clinical documents of high quality such as study concepts, study protocols and reports, investigator brochures, NDA/MAA registration documents and publications. Reviews and signs off on clinical documents related to clinical studies as outlined by the manager. Builds and maintains effective relationships with clinical key opinion leaders in various different areas of disease in which Taiho is developing drugs. Will collaborate with all department heads within TOI (Head of Clinical Research and Head of Clinical Operations) to establish operational plans and timelines for respective studies within each of the development programs for review by the SVP Clinical Development or the Chief Medical Officer. Keeps SVP Clinical Development or the Chief Medical Officer current on status of clinical trials and provides ongoing risk assessments for the study conduct and operational risks. Co-responsible with SVP Clinical Development, Project Management, Head of Clinical Research, and Head of Clinical Operations for delivering the design, conduct, and reporting of clinical trials within agreed timelines. Collaborates with Clinical Operations/trial management in vendor oversight. Continually assesses if adequate resources are available to meet clinical trial deliverables and milestones. Education/Certification Requirements Successful completion of MD training mandatory; completion of training in a medical sub-specialty with a completed fellowship in a Hematology-Oncology program preferred. Hematology or Oncology Board eligibility or certification preferred. Clinical practice experience of a minimum of 1-3 years preferred. Knowledge, Skills, And Abilities 4-7 years combined experience in academic and/or industry oncology clinical research and drug development, including experience as medical monitor or investigator on a clinical oncology trial. At least 2 years in drug development industry in oncology and with previous exposure to clinical development, regulatory and statistical activities such as, e.g., (co-)authoring and reviewing of documents such as clinical trial protocols, statistical analysis plans, IND AR, NDA AR, PSUR, DSUR, IB, ICF, orphan drug designations, regulatory briefing document, etc. is preferable. Working knowledge of the drug development process in the USA and EU is required Experience in direct interactions with US and/or EU Regulatory authorities is highly preferred. Highly detail and quality oriented. Excellent presentation skills. Ability to learn, integrate complex information, and communicate clinical information in easily understandable fashion to non-clinical team members. Ability to understand and implement prioritization of deliverables as well as recogni