Sr. Director, Biomarker & Companion Diagnostic Development - Taiho Oncology

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 Director, Biomarkers and CDx Development, you will play a pivotal role in our mission, leveraging your expertise to drive innovative precision medicine strategies 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: 

• Reporting to VP, Biomarker and Companion Diagnostic Development, this position has responsibility for the strategy related to the identification and selection of clinical biomarkers to be incorporated into early-stage clinical trials in collaboration with TPC’s research organization and, where appropriate, for the further development, registration and approval of companion diagnostics.  Works cross-functionally with internal departments and external partners. 

Performance Objectives: 

• Design of biomarkers strategy in collaboration with Taiho Japan and/or Taiho Oncology Inc (TOI) GPDT members  
• Develop Companion Diagnostic strategy for relevant compounds. 
• Responsible for execution of translational and biomarkers aspects within Phase1-3 studies for US and EU or global studies. 
• Responsible for liaising with Clinical Development Leads in Clinical Development in implementing the biomarker strategies. 
• Collaborates with relevant departments within TOI to establish operational plans and timelines/cost for respective studies within each of the development programs  
• Creating/reviewing and editing biomarkers aspects in various documents and regulatory submissions. 
• Executes the content and scope for contracts with labs and diagnostic companies. 
• Direct operational aspects of predictive and prognostic biomarkers deployment (eg. kits, tracking, timely analysis etc.) 
• Where appropriate, in collaboration with Clinical Development, lead the identification, evaluation and selection process for a Companion Diagnostic partner company. 
• Where appropriate, work directly with the Companion Diagnostic partner company to ensure the simultaneous development and registration via a PMA or equivalent, of all companion diagnostic tests/devices required for use with Taiho Oncology products, including such activities as contracting, document review and approval, oversight, budget development, budget management and dispute resolution.  
• May manage employees 

Education/Certification Requirements: 

• MD or PhD with Oncology training/experience in the relevant fields 

Knowledge, Skills, and Abilities: 

• 6-10 years’ combined experience in oncology drug development and/or assay development with meaningful experience in companion diagnostic/assay development. 
• Extensive knowledge of the oncology drug development and device development process in the USA and EU is required 
• Prior experience managing people and leading teams is a plus 
• Experience in direct interactions with US and/or EU Regulatory authorities, particularly with CDRH is necessary.   
• 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 prioritize deliverables as well as recognize and resolve conflicts in priorities 
• Ability to work independently and collaboratively, as required, in a fast-paced matrix team environment consisting of internal and external team members.  
• A positive attitude, flexibility and a proactive thought process. 
• Ability to read, analyze and interpret scientific and technical information and data. 
• Excellent written and oral communication skills 
• Ability to work with mathematical concepts such as probability and statistical measures. 
• Strong computer skills in MS Office products. 
• Must be able to travel domestically and internationally on a reasonably frequent basis including some weekend travel). 
• The incumbent in this position may be required to perform other duties, as assigned. 

The pay range for this position at commencement of employment is expected to be between 240,000 - $284,000 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, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on 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 “at-will 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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