Senior Leader, Clinical Pharmacology & Pharmacometrics

Taiho Oncology, Inc.; Princeton (NJ); Hybrid; USD 157,000 - 185,000; Full time

Job summary

Taiho Oncology, Inc. in Princeton, NJ is seeking a Clinical Pharmacology and Pharmacometrics (CPP) Expert to lead PK/PKPD analyses, modeling, and regulatory submissions for the oncology portfolio.

You will serve on project teams, oversee study designs, data interpretation, and cross-functional coordination with Biostatistics, Data Management, Translational Pharmacology, and Development groups to translate findings into development plans.

Qualifications

• PhD, PharmD or equivalent in pharmacokinetics, pharmaceutics, pharmacology, or similar area.
• Minimum 5 years’ experience, including postdoctoral fellowship; title commensurate with experience.
• Hands-on PK analysis experience and ability to generate outputs.
• Experience with industry standard PK, PK/PD pharmacometrics software/tools.
• Strong interpersonal skills and ability to manage external consultants and CROs.
• Strong written, presentation, and verbal communication skills.

Responsibilities

• Oversee design, analysis, interpretation, and reporting of PK/PD data from clinical studies.
• Lead PK/PKPD modeling and simulations; author sections of Clinical Study Reports and CP regulatory documents.
• Plan and review study designs, analysis plans, data interpretation, and regulatory filings.
• Serve as study director for Clinical Pharmacology studies in healthy volunteers.
• Review PK/PD and bioanalytical data; overseeData Transfer Agreements with vendors.
• Collaborate with Biostatistics, Data Management, Translational Pharmacology, and other groups to interpret data.

Skills

PK analysis

PK/PD modeling

Regulatory writing

External vendor mgmt

Cross-functional collaboration

Communication skills

Education

PhD or PharmD or equivalent

Tools

PK/PD software

Job description

Taiho Oncology, Inc. in Princeton, NJ is seeking a Clinical Pharmacology and Pharmacometrics (CPP) Expert to lead PK/PKPD analyses, modeling, and regulatory submissions for the oncology portfolio.

You will serve on project teams, oversee study designs, data interpretation, and cross-functional coordination with Biostatistics, Data Management, Translational Pharmacology, and Development groups to translate findings into development plans.