Taiho Oncology, Inc. · 18 hours ago
Sr. Director, Clinical Pharmacology & Pharmacometrics
Pleasanton, CA
Full-time
Hybrid
Director/Executive
$263K/yr - $310K/yr
10+ years expTaiho Oncology, Inc. is dedicated to improving the lives of patients with cancer through innovative science and a strong employee-focused culture. The Sr. Director, Clinical Pharmacology & Pharmacometrics will oversee clinical pharmacology activities and develop strategies for oncology compounds, ensuring effective collaboration across various teams and leading bioanalytical efforts.
BiotechnologyHealth CareMedicalOncologyPharmaceutical
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
Qualification
Required
Advanced degree (Doctoral or Ph.D. is preferable) in pharmacology-related discipline. If a candidate has a master's degree, additional industry experience will be required
A minimum of 10 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 experience successfully managing a team and willingness to put the organization and team's needs first
Experience with prior regulatory interactions, NDA/BLA submissions highly desirable
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
Benefits
Annual bonus/incentive comp plans
Potential long term incentive plan
Discretionary awards
Full range of medical, financial, and/or other benefits
401(k) eligibility
Various paid time off benefits, such as vacation, sick time, and parental leave
Company
Taiho Oncology, Inc.
The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers.
201-500 employees
H1B Sponsorship
Taiho Oncology, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (5)
2023 (1)
2021 (3)
Funding
Current Stage
Growth StageLeadership Team
Tim Whitten
CEO & President
Michael Schick
Senior Vice President, Chief Commercial Officer
Recent News
2025-12-03
Pharma Letter
2025-11-22
Company data provided by crunchbase