Director, External Research

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.HybridEmployee Value Proposition:Utilizing scientific expertise in hematology and oncology, the Director, External Research will enjoy collaborating with Medical Affairs Product Leads on development of the areas of interest, execution of research collaborations and continued monitoring and reporting on key milestones. This position will mentor, develop and have oversight of a direct report responsible for day-to-day operations for the research program including Investigator Initiated Trials/Collaborative Research (IITs/CR) and Independent Medical Education Programs.Position Summary:The Director is accountable for the External Research Program (IITs/CRs) for the Taiho Oncology Inc. (TOI) portfolio in the US and Europe. This role requires scientific expertise and experience in development and leads the IIT and collaborative program with continuous monitoring and reporting of key milestones. In addition to interactions with Medical Affairs Product Leads, this role will engage with Medical Field team, global Sponsor-Investigators and lead the process for assessment of the IITs/Collaborative Research proposals, approvals, and communications. Oversight of monitoring of the key milestones and appropriate action, and reporting will be essential for this role. The candidate must ensure that Medical Affairs adheres to all applicable SOPs, laws, and regulations for compliance and quality.Performance Objectives:Leads, develops, and continuously improves the IITs/Collaborative Research Program for the TOI portfolio in the US and Europe, including scientific/clinical assessment of proposals, project management, and interface with Sponsor-Investigators.Monitoring and tracking of key milestones, analysis of scientific data from IITs/Collaborative studies and summarizes information for relevant reporting and communications, contributions to Life Cycle Management Plan, and reports to Medical Affairs Leadership.Interfaces with Medical Affairs Product Leads, Medical Field Team, external Investigators and external research collaborative programs administration and committees (as per TOI policies), facilitate review of data findings with Sponsor-Investigators.Leads the IIT/Collaborative Research Review Committees for clinical and pre-clinical trials and ensures accurate documentation of meeting minutes and follow-up with the Sponsor-Investigators.Coordinates with Medical Affairs Product Leads on the execution of research collaborations to ensure continued progress and deliverables. Ensures timely negotiation and execution of trial agreements in collaboration with Legal.Responsible for accurate budget management, reporting of IIT/Collaborative Research metrics, and key milestone achievements to Medical Affairs Leadership.Develops and updates IIT/Collaborative Research SOPs & Processes to ensure compliance with guidelines and Quality principles. Responsible for ensuring that regulatory and operational aspects of IITs/Collaborative Research trials are aligned with country specific requirements.Works with Information Technology, Quality Assurance, Compliance, and other cross functional team members to optimize IIT system and implementation of processes, including review and approval, tracking of milestones as per SOPs and guidance.Oversight of the direct report accountable for Independent Medical Education program working with CME Review Committee Lead and Product Medical Leads.Education/Certification Requirements:Masters in Science is required. Doctoral degree in scientific discipline or PhD preferred.Knowledge, Skills, and Abilities:8-10 years Hematology / Oncology Medical Affairs and Clinical experience preferred.At least 2-5 years’ experience in management of IITs/Collaborative Research programs required.Development and tracking of Key Performance Indicators is required.Strategic thinker & ability to work in a fast-paced environment.Able to manage and provide oversight to a direct report, organized and able to plan, prioritize and manage all tasks related to the position.Expert knowledge of FDA, EMA and local EU regulations, ICH, GCP, GDPR, ACCME, and UEMS-EACCME guidelines are required.Excellent prioritization, organizational skills, and metric-driven project management will be essential for this role.A team player able to work in a dynamic environment with attention to high quality results.Self-motivated and self-directed with the ability to function independently as well as part of a cohesive team.Excellent English communication skills, both verbal and written.Ability to work with mathematical concepts.Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.Ability to assess situations to determine the importance, urgency and risks, and present team with recommendations is required.Up to 25 % travel required.

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