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:

Oversee Clinical Pharmacology activities in support of development of Taiho programs.

 

Position Summary:

Position will be in charge of the clinical pharmacology (CP) and pharmacokinetics (PK) 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.
+ Collaborating with Clinical Development, Biostatistics, Clinical Operations and Regulatory to incorporate the bioanalysis for PK and CP components and activities into the final protocols.


* Final analysis and reporting of bioanalysis for PK and CP data generated by TOI-sponsored clinical trials and writing or reviewing the appropriate sections of the following documents:
+ Clinical Study Reports.
+ Investigator Brochures.
+ Regulatory Documents, including NDAs and MAAs and responses to questions from regulatory authorities.
+ Academic publications, including scientific meeting abstracts and peer-reviewed articles.


* CP representative for specific programs in Global Development Teams.


* Lead the implementation of bioanalytical activities for CP/PK by:
+ Arranging what external or Taiho Pharmaceutical Company laboratories and systems will be used to do the bioanalytical work for PK samples retrieved in TOI run clinical trials.
+ Leading and providing the technical component of contracting with external bioanalysis vendors.
+ Collaborating closely with related departments such as data management, biostatistics, clinical operations etc.

to ensure full and effective integration of bioanalysis wit...