Sr. Manager, Clinical Pharmacology & Pharmacometrics

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.

About the role

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 Taiho Oncology’s oncology portfolio. The Clinical Pharmacology Expert will represent the Clinical Pharmacology function at Project Teams and Clinical Study Teams.

Responsibilities

• Perform pharmacokinetic analysis and PK/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.
• 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 and PK/PD.
• Oversee 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 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.

Requirements

• PhD, PharmD, or equivalent in pharmacokinetics, pharmaceutics, pharmacology, or a similar area.
• Minimum 5 years’ experience, including postdoctoral fellowship.
• Hands-on experience with PK analysis and generating outputs.
• Experience with industry-standard PK, PK/PD, and 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.

Pay

The pay range for this position at commencement of employment is expected to be between $157,250 and $185,000 annually. Base pay may vary depending on market location, job-related knowledge, skills, and experience. The total compensation package may also include annual bonus/incentive comp plans, potential long-term incentive plans, and discretionary awards.

Benefits

• Full range of medical, financial, and other benefits, including 401(k) eligibility.
• Various paid time off benefits, such as vacation, sick time, and parental leave.

Locations: Princeton, NJ / Pleasanton, CA