Sr. Director, Clinical Pharmacology & Pharmacometrics

Taiho Oncology, Inc.•Pleasanton, CA

4d•$263,000 - $310,000•Hybrid

About The Position

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).

Requirements

Advanced degree (Doctoral or Ph.D. is preferable) in pharmacology related discipline.
A minimum of 8 years of industry experience with focus on clinical development including oncology.
Significant experience of PK, and PK/PD 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 effective Management experience
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 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 within TOI activities.
Collaboration with biomarker department and conduct PK/PD analysis (pharmacodynamic).
Maintain collaboration with TPC (Taiho Pharmaceutical Japan) PK department.
Build CP department at TOI and provide supervision/mentorship as needed.