Sr. Director, Clinical Pharmacology & Pharmacometrics

Taiho Oncology seeks a Senior Director, Clinical Pharmacology & Pharmacometrics, with strong scientific and strategic leadership in oncology compound development.

Hybrid work arrangement.

The Senior Director, Clinical Pharmacology & Pharmacometrics, Modeling and Simulation will lead clinical pharmacology (CP), pharmacometrics, and modeling & simulation (PopPK, ER, QSP) activities for oncology compounds, ensuring safe, effective, and regulatory‑ready drug candidates.

• Develop overall CP 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 finalization of 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 QSP.
  • Collaborate with Clinical Development, Biostatistics, Clinical Operations, and Regulatory to incorporate PK and CP components into protocols, study reports, and regulatory submissions.
  • Support regulatory submissions by writing or reviewing CP 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.
  • Contribute to academic publications, including scientific meeting abstracts and peer‑reviewed articles.
  • Mentor and lead junior scientists in quantitative modeling efforts to meet department and program objectives.
• Serve as CP representative for specific programs in Global Development Teams.
• Collaborate closely with related departments (data management, biostatistics, clinical operations, biomarker) to ensure integration of PK-related data within TOI activities.
• Maintain collaboration with TPC (Taiho Pharmaceutical Japan) PK department.
• Manage a team of CP professionals and provide supervision/mentorship as needed.

• Advanced degree (Doctoral or Ph.D. preferable) in pharmacology-related discipline or quantitative sciences; a master’s degree requires additional industry experience.

• Minimum 12 years of industry experience focusing on clinical development in oncology.
• Significant experience with PK, PK/PD, modeling & simulation (PopPK, ER, QSP) in clinical trials and design/execution of CP and PK studies.
• Operational experience in CP/PK oncology clinical development.
• Knowledge of ICH/FDA/EU guidelines for CP/PK.
• Experience working in interdisciplinary teams.
• Excellent written and oral communication.
• Demonstrated team‑management experience and team‑first mindset.
• Experience with regulatory interactions; NDA/BLA submissions highly desirable.
• Deep working knowledge of the drug development process.
• Strong multitasking, attention to detail, and quality focus.
• Ability to read, analyze, and interpret professional journals and technical manuscripts.
• Ability to write reports, procedures, and present information effectively.
• Ability to appropriately analyze CP/PK data, including pop‑PK analysis and modeling.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret abstract and concrete concepts.
• Experience with Data Management software, Windows, and MS Office (Word, Excel, PowerPoint, Win Nonlin).
• Ability to understand documents in English.