Taiho Oncology, Inc. · 11 hours ago
Associate Director, Clinical Pharmacology & Pharmacometrics
Pleasanton, CA
Full-time
Hybrid
Lead/Staff, Director/Executive
$195K/yr - $229K/yr
8+ years expTaiho Oncology, Inc. is dedicated to improving the lives of patients with cancer through innovative drug development. The Associate Director will lead Clinical Pharmacology and Pharmacometrics activities, overseeing study design, data analysis, and regulatory submissions for oncology compounds.
BiotechnologyHealth CareMedicalOncologyPharmaceutical
Responsibilities
Develop the overall CPP strategy and reporting plans for all oncology compounds developed in TOI-sponsored clinical trials by:
Serve as the Clinical Pharmacology and Pharmacometrics lead on cross-functional drug development teams
Lead and manage clinical pharmacology study design, data analysis, data interpretation, and reporting
Provide input to Phase 1/2/3 clinical study design and registrational strategy
Develop modeling and simulation strategies, plans, and execution
Participate in interactions with health authorities
Contributing and reviewing clinical pharmacology-related sections of Statistical Analysis Plans
Provide expertise to Business Development teams to assess external acquisitions
Conduct or oversee data analysis and reporting of PK data generated by TOI-sponsored clinical trials and writing or reviewing the reports or the appropriate sections of the following documents:
Clinical Study Reports
Investigator Brochures
Population PK and/or Exposure-Response reports
Regulatory Documents, including NDAs and MAAs and responses to questions from regulatory authorities
Academic publications, including scientific meeting abstracts and peer-reviewed articles
Lead the implementation of operational activities for clinical pharmacology by:
Leading and providing the technical component of contracting with external vendors
Managing the external vendors and overseeing all processes to ensure efficient and high-quality data production
Collaborating closely with related departments such as data management, biostatistics, clinical operations etc. to ensure full and effective integration of PK dataset within TOI activities
Provide support of quantitative methodology, pharmacometrics tools, software, hardware, and related business processes
Qualification
Required
PhD or MS degree in Drug Metabolism and Pharmacokinetics related discipline
A minimum of 8 years (PhD)/ 15 years (MS) of industry experience with a significant component of experience of clinical PKPD analyses in clinical trials and the design and execution of clinical pharmacology studies
Hands-on experience in quantitative data analysis, data visualization skills, population PK/PD analysis
Operational experience in clinical pharmacology part of oncology clinical development with experience in vendor/CRO relationships
A working knowledge of the ICH/FDA/EU guidelines for DMPK
Excellence in written and oral communication
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