Associate Director, Clinical Pharmacology & Pharmacometrics

Associate Director, Clinical Pharmacology & Pharmacometrics

Pleasanton, CA, USA

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:

At Taiho Oncology, we recognize the critical role that Clinical Pharmacology and Pharmacometrics (CPP) plays in the development of oncology compounds. Our Performance Objectives outline a comprehensive approach to developing the overall CPP strategy and reporting plans for all TOI‑sponsored clinical trials, ensuring the success of our drug development endeavors. This role will serve as Clinical Pharmacology (CP) Expert on Project teams and lead CP program(s).

Position Summary:

Position will support the execution of Clinical Pharmacology and Pharmacometrics (CPP) activities related to oncology compound development for Taiho Oncology, Inc. (TOI).

Performance Objectives:

• 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.
• 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.

Education/Certification Requirements:

• PhD or MS degree in Drug Metabolism and Pharmacokinetics related discipline.

Knowledge, Skills, and Abilities:

• 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…