Sr. Director, Clinical Pharmacology & Pharmacometrics

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:

​​​​​Senior Leader, provides scientific and strategic leadership to bridge the gap between preclinical research and late-stage clinical development, ensuring that pharmacology data underpins safe, effective, and regulatory-ready drug candidates. The Senior Director oversees Clinical Pharmacology activities in support of development of Taiho programs​ with the use of modeling & simulation approaches​​​. 

 

Position Summary:

​​The Senior Director, Clinical Pharmacology & Pharmacometrics, Modeling and Simulation will be in charge of the clinical pharmacology (CP), pharmacometrics and Modeling & Simulation (PopPK, ER, QSP) activities related to oncology compound development for Taiho Oncology, Inc.

(TOI).

 

Performance Objectives:


* ​​​Develop the overall CP strategy and reporting plans for oncology compounds developed in TOI-sponsored clinical trials by:
+ ​Writing or overseeing the writing of all CP/PK sections of Phase I-III trials.
+ ​Reviewing 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).
+ ​Collaborating 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 dat...