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

Hybrid work arrangement.

Position Summary

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.

Performance Objectives

• 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.

Education/Certification Requirements

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

Knowledge, Skills, and Abilities

• 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, WinNonlin).
• Ability to understand documents in English.

Pay Range

The expected first‑year base salary ranges from $263,500 to $310,000 annually, with additional compensation elements such as annual bonus, potential long‑term incentive, discretionary awards, and a comprehensive benefits package including 401(k) eligibility, paid time off, and parental leave.

Location

Pleasanton, CA and Princeton, NJ.

Equal Opportunity Employer

Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Applicants who need accommodations during the application or employment process should contact Taiho Oncology provides reasonable accommodations to employees with disabilities in accordance with the law. Pursuant to applicable Fair Chance Laws, we will consider qualified applicants with arrest and conviction records.

The incumbent in this position may be required to perform other duties as assigned.