Sr. Manager, Clinical Pharmacology & Pharmacometrics

Taiho Oncology, Inc.•Pleasanton, CA

7d•$157,250 - $185,000•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. 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). This role is responsible for overseeing the design, analysis, interpretation, and reporting of pharmacokinetic, pharmacodynamic, drug disposition, and drug metabolism data from clinical studies for TOI oncology portfolio and representing Clinical Pharmacology function at Project Teams and Clinical Study Teams.

Requirements

PhD, PharmD or equivalent in pharmacokinetics, pharmaceutics, pharmacology, or similar area.
Minimum 5 years’ experience, including postdoctoral fellowship; position title commensurate with experience.
Hands-on experience with PK analysis and generating outputs.
Experience with industry standard PK, PK/PD pharmacometrics software and tools.
Strong interpersonal skills and ability to effectively manage external consultants and third-party CROs.
Strong problem solver who is highly organized with the ability to lead in an environment with rapidly changing priorities.
Strong written, presentation, and verbal communication skills are essential.

Responsibilities

Responsible for performing pharmacokinetic analysis and PK and PK/PD modeling and simulations; lead/author, or contribute to relevant sections of Clinical Study Reports, Clinical Pharmacology related regulatory documents and draft relevant sections in support of clinical development plans, and provide Clinical Pharmacology and Pharmacometrics perspective on cross-functional teams, including Clinical Study Teams.
Plan and review study designs, analysis plans, data analysis, and interpretation of PK, PK/PD, as well as planning, implementation and organization of regulatory filings and presentation of data at cross-functional teams, department meetings, conferences, and regulatory meetings. Serve as a study director for Clinical Pharmacology studies in healthy volunteers.
Review PK/PD and bioanalytical data. Oversee the Data Transfer Agreements with vendors.
Contribute to the design and development of Clinical Pharmacology studies, including DDI, Food Effect, ADME, and related studies, as well as the translation of findings into an understanding of in vivo metabolic fate.
Work closely with other scientists and disciplines, including Biostatistics, Data Management, Translational Pharmacology, Pharmaceutical Development, CMC, Toxicology, Clinical Development, and other relevant groups, to plan, analyze and interpret PK, biotransformation, and metabolism data.
Contribute to improvements in processes within the department as well as across functional areas affecting Clinical Pharmacology, such as Biostatistics, Drug Safety and Clinical Operations.
The incumbent in this position may be required to perform other duties, as assigned.