Sr. Director, Clinical Pharmacology & Pharmacometrics

Taiho Oncology, Inc.; Pleasanton (CA); Hybrid; USD 264,000 - 310,000; Full time

Job summary

Taiho Oncology, Inc. is seeking a Senior Director of Clinical Pharmacology & Pharmacometrics to lead CP/PK activities for oncology programs. This hybrid role combines on-site presence with collaboration across functions at our Pleasanton, CA location.

You will oversee modeling & simulation, PK/PD analyses, and dose selection, guiding CP strategy and regulatory submissions while mentoring a team of scientists in a fast-paced environment.

Qualifications

• A minimum of 12 years of industry experience with focus on clinical development including oncology.
• Significant PK/PD and modeling & simulation experience (PopPK, ER, QSP) in clinical trials.
• Operational CP/PK experience in oncology development.
• Knowledge of ICH/FDA/EU CP/PK guidelines.
• Interdisciplinary team experience and strong communication skills.
• Experience with regulatory NDA/BLA submissions is desirable.
• Deep understanding of the drug development process.

Responsibilities

• Develop CP strategy and reporting plans for oncology compounds in TOI trials.
• Write or oversee CP/PK sections of Phase I-III trials.
• Collaborate with teams to integrate CP into protocols and regulatory documents.
• Mentor junior scientists and lead quantitative modeling efforts.

Skills

Clinical pharmacology

Pharmacometric modeling

PK/PD analysis

Team leadership

Regulatory submissions

Data integration

Modeling & Simulation

Education

Advanced degree (PhD preferred)

Tools

WinNonlin

Data Management software

MS Office

Job description

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: 3-days per week on-site

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 datasets from multiple sources.
  • Integrate pharmacometric workflows using modern data architecture, data science engineering, and advanced computing.
  • Collaborate with cross-functional teams (clinical pharmacology, pharmacometrics, regulatory, data science) to implement modeling solutions.
  • Academic publications, including scientific meeting abstracts and peer-reviewed articles.
  • Mentor and lead junior scientists in quantitative modeling efforts to deliver on department and program objectives.
• CP representative for specific programs in Global Development Teams.
• Collaborate closely with related departments such as data management, biostatistics, clinical operations etc. to ensure full and effective integration of PK-related data within TOI activities.
• Collaboration with biomarker department and conduct PK/PD analysis (pharmacodynamic).
• Maintain collaboration with TPC (Taiho Pharmaceutical Japan) PK department.
• Manage a Team of talented individuals within CP department at TOI and provide supervision/mentorship as needed.

Education/Certification Requirements

• Advanced degree (Doctoral or Ph.D. is preferable) in pharmacology-related discipline or quantitative sciences. If a candidate has a master’s degree, additional industry experience will be required.

Knowledge, Skills, And Abilities

• A minimum of 12 years of industry experience with focus on clinical development including oncology.
• Significant experience of PK, PK/PD, Modeling & Simulation including PopPK, ER and QSP 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.

The pay range for this position at commencement of employment is expected to be between $263,500 - $310,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment.

If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

#Location-Pleasanton, CA

#Location-Princeton,NJ

Equal Opportunity Employer Information:

Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email [e-mail]. Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.

The incumbent in this position may be required to perform other duties, as assigned.