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. Taihos 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 cuttingedge 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 worldclass clinical development organization and stateoftheart facilities: these and other resources empower us to innovate and touch the lives of more and more patients. Its our work our passion and our legacy. We invite you to join us.

Hybrid

Employee 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 of research collaborations and continued monitoring and reporting on key milestones.

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 SponsorInvestigators 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 SponsorInvestigators.
• 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 SponsorInvestigators.
• Leads the IIT/Collaborative Research Review Committees for clinical and preclinical trials and ensures accurate documentation of meeting minutes and followup with the SponsorInvestigators.
• Coordinates with Medical Affairs Product Leads on the of research collaborations to ensure continued progress and deliverables. Ensures timely negotiation and 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:

• 810 years Hematology / Oncology Medical Affairs and Clinical experience preferred.
• At least 25 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 fastpaced 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 UEMSEACCME guidelines are required.
• Excellent prioritization organizational skills and metricdriven project management will be essential for this role.
• A team player able to work in a dynamic environment with attention to high quality results.
• Selfmotivated and selfdirected 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

The pay range for this position at commencement of employment is expected to be between $221850 and $261000 annually. This pay range is based on the market range for positions of this type. However base pay offered may vary depending on multiple individualized factors including market location jobrelated knowledge skills and experience. The total compensation package for this position may also include other elements including a signon bonus restricted stock units commissions and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired employee will be in an atwill position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

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