Sr. Director, Clinical Pharmacology & Pharmacometrics

Taiho Oncology, Inc.•Pleasanton, CA

23h•$263,500 - $310,000•Hybrid

About The Position

Taiho Oncology is seeking a Sr. Director, Clinical Pharmacology & Pharmacometrics to provide scientific and strategic leadership in the oncology space. This role bridges preclinical research and late-stage clinical development, ensuring pharmacology data supports safe, effective, and regulatory-ready drug candidates. The Senior Director will oversee Clinical Pharmacology activities for Taiho programs, utilizing modeling and simulation approaches. The position is hybrid and focuses on improving the lives of patients with cancer through cutting-edge science and a growing portfolio. The Senior Director, Clinical Pharmacology & Pharmacometrics, Modeling and Simulation will be responsible for clinical pharmacology (CP), pharmacometrics, and Modeling & Simulation (PopPK, ER, QSP) activities for oncology compound development at Taiho Oncology, Inc. (TOI).

Requirements

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.
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.
Ability to interpret abstract and concrete concepts.
Experience using Data Management software, Windows and MS Office products specifically Word, Excel, PowerPoint, and WinNonlin.
The employee is required to understand documents in English.

Nice To Haves

Experience with prior regulatory interactions, NDA/BLA submissions highly desirable.

Responsibilities

Develop the overall CP strategy and reporting plans for oncology compounds developed 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.
Contribute to academic publications, including scientific meeting abstracts and peer-reviewed articles.
Mentor and lead junior scientists in quantitative modeling efforts to deliver on department and program objectives.
Serve as the 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 the biomarker department and conduct PK/PD analysis (pharmacodynamic).
Maintain collaboration with TPC (Taiho Pharmaceutical Japan) PK department.
Manage a team of talented individuals within the CP department at TOI and provide supervision/mentorship as needed.