Sr. Director, Clinical Pharmacology & Pharmacometrics
About the role
Taiho Oncology is seeking a Senior Director, Clinical Pharmacology & Pharmacometrics, Modeling and Simulation to bridge the gap between preclinical research and late-stage clinical development. This role focuses on ensuring pharmacology data supports safe, effective, and regulatory-ready drug candidates.
Responsibilities
Develop the overall Clinical Pharmacology strategy and reporting plans for oncology compounds in TOI-sponsored clinical trials.
Write or oversee the writing of all CP/PK sections of Phase I-III trials.
Review the finalization of all CP/PK-related sections of Statistical Analysis Plans.
Develop and execute computational modeling strategies for pharmacometric analyses, including PK/PD modeling, exposure–response modeling, and quantitative systems pharmacology (QSP).
Collaborate with Clinical Development, Biostatistics, Clinical Operations and Regulatory to incorporate PK and CP components and activities into the final protocols, clinical study reports and regulatory submission documents.
Support regulatory submissions by writing or reviewing clinical pharmacology components of regulatory documents.
Integrate diverse datasets (clinical trial data, real-world data, patient characteristics, disease biology) to optimize dose selection, dosing regimens, and study designs.
Curate, visualize, and manage large, complex datasets from multiple sources.
Integrate pharmacometric workflows using modern data architecture, data science engineering, and advanced computing.
Collaborate with cross-functional teams (clinical pharmacology, pharmacometrics, regulatory, data science) to implement modeling solutions.
Mentor and lead junior scientists in quantitative modeling efforts to deliver on department and program objectives.
CP representative for specific programs in Global Development Teams.
Collaborate closely with related departments such as data management, biostatistics, clinical operations etc. to ensure full and effective integration of PK-related data within TOI activities.
Collaborate with biomarker department and conduct PK/PD analysis (pharmacodynamic).
Manage a Team of talented individuals within CP department at TOI and provide supervision/mentorship as needed.
Requirements
Advanced degree (Doctoral or Ph.D. is preferable) in pharmacology-related discipline or quantitative sciences.
If a candidate has a master’s degree, additional industry experience will be required.
Minimum of 12 years of industry experience with focus on clinical development including oncology.
Significant experience of PK, PK/PD, Modeling & Simulation including PopPK, ER and QSP analyses in clinical trials and the design and execution of CP and PK studies in oncology.
Operational experience in CP/PK part of oncology clinical development.
A working knowledge of the ICH/FDA/EU guidelines for CP/PK.
Prior experience working in an interdisciplinary team.
Excellence in written and oral communication.
Demonstrated experience successfully managing a team and willingness to put the organization and team’s needs first.
Experience with prior regulatory interactions, NDA/BLA submissions highly desirable.
Deep working knowledge of drug development process.
Ability to multi-task.
Attention to detail with a consistent focus on quality.
Ability to read, analyze, and interpret professional journals and technical manuscripts.
Ability to write reports, and procedures.
Ability to effectively present information and respond to questions from internal and external clients.
Ability to appropriately analyze CP/PK related data including pop-PK analysis and modeling.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Experience using Data Management software, Windows and MS Office products specifically Word, Excel, PowerPoint, and WinNonlin.
Qualifications
Education/Certification Requirements:
Advanced degree (Doctoral or Ph.D. is preferable) in pharmacology-related discipline or quantitative sciences.
If a candidate has a master’s degree, additional industry experience will be required.
Skills and Abilities
Knowledge, Skills, And Abilities:
A minimum of 12 years of industry experience with focus on clinical development including oncology.
Significant experience of PK, PK/PD, Modeling & Simulation including PopPK, ER and QSP analyses in clinical trials and the design and execution of CP and PK studies in oncology.
Operational experience in CP/PK part of oncology clinical development.
A working knowledge of the ICH/FDA/EU guidelines for CP/PK.
Prior experience working in an interdisciplinary team.
Excellence in written and oral communication.
Demonstrated experience successfully managing a team and willingness to put the organization and team’s needs first.
Experience with prior regulatory interactions, NDA/BLA submissions highly desirable.
Deep working knowledge of drug development process.
Ability to multi-task.
Attention to detail with a consistent focus on quality.
Ability to read, analyze, and interpret professional journals and technical manuscripts.
Ability to write reports, and procedures.
Ability to effectively present information and respond to questions from internal and external clients.
Ability to appropriately analyze CP/PK related data including pop-PK analysis and modeling.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Experience using Data Management software, Windows and MS Office products specifically Word, Excel, PowerPoint, and WinNonlin.
Benefits
The employee is required to understand documents in English. The pay range for this position at commencement of employment is expected to be between $263,500 - $310,000 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 annual bonus/incentive comp plans, potential long term incentive plan, 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 a candidate/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.