VP, Clinical 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, 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 leading development teams (including Global Product Development Teams) and accountability for program deliverables. The Vice President has responsibility of the design and execution of Phase I, II, III trials of Taiho oncology NCEs and/or “ancillary trials” (eg- PKPD and QT/QTc trials).  In addition, this position will review and provide input into overall strategic development of both pre-clinical and clinical Taiho Oncology Inc., (TOI), compounds, in collaboration with Taiho Japan Research.

Performance Objectives:

• Lead Development Teams (including Global Product Development Teams - GPDT) for one or multiple programs and take accountability for program deliverables.
• Leads the clinical development strategy including the design, writing and execution of Phase I-III and “ancillary” trials.
• Supervises and manages the clinical and statistical aspects of clinical trials for Taiho for which he/she is responsible. 
• Provides strategic input into Taiho clinical development programs.
• Provides strategic input to Taiho preclinical programs in collaboration with Research Teams in Japan.
• Provides financial leadership, oversight and strategic business decision support for all Phase development program budgeting in coordination with the Head of Clinical and Medical Operations (if present).
• Assumes responsibilities as medical monitor or lead medical monitor, as needed.
• Will collaborate with all department heads within TOI (e.g., Head of Clinical, Medical Operations and Project Management, or functional equivalents) to establish operational plans and timelines for respective programs/studies for which he/she will be co-responsible.  
• Keeps management current on project status and provides ongoing risk assessments.
• Continually reviews and ensures that adequate resources are available to meet project deliverables and milestones.
• Develops and implements continuous improvement processes for assigned projects and programs. Assist the Head of Clinical development in establishing or improving processes for Clinical Development.
• Author regulatory documents as required.
• Perform BD&L activities as required.
• Supervise Medical Monitors or Research Scientists as required.
• Assumes responsibilities as medical monitor or lead medical monitor, as needed.
• Mentoring and training of junior staff in Clinical Development and other departments as required.
• Performs other duties as required.

Education/Certification Requirements:

• MD required.  Hematology or Oncology training and residency and/or fellowship training and Board eligibility or certification preferred.

Knowledge, Skills, and Abilities:

• 10 years combined experience in academic/clinical and/or industry oncology clinical research and drug development, including experience as lead medical monitor or principal investigator of an oncology trial.
• 5 years of a leadership or key role in industry involving oncology programs that involved direct or indirect management of cross-functional areas (Statistical review and write up of clinical trial results, written or verbal interaction/presentations to FDA or EMA, etc.).
• Strong working knowledge of the drug development process in the USA/EU is required. 
• Direct work experience with US and/or EU Regulatory authorities is highly preferred.
• Highly detail and quality oriented.
• Excellent presentation skills.
• Ability to persuade and negotiate with project team members and senior management. 
• A positive hands-on attitude, flexibility and a proactive thought process. 
• Must be able to travel domestically and internationally.

The pay range for this position at commencement of employment is expected to be between $349,000 – $411,000 annually; 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, 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 PTO, 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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