Senior Manager, CPP & Pharmacometrics – Hybrid

Taiho Pharma Canada, Inc.

Princeton (NJ)

Hybrid

USD 157,000 - 185,000

Full time

14 days+

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Benefits offered by this job

Medical benefits
401(k)
Paid time off

Job summary

Taiho Oncology seeks a Sr. Manager, Clinical Pharmacology & Pharmacometrics to lead CP strategy across TOI-sponsored trials.

You will oversee PK/PKPD analyses, develop models, and contribute to regulatory submissions, working with cross‑functional teams to translate findings into actionable development plans. Ideal candidates have 5+ years in CP/PK, strong communication skills, and experience supervising external CROs.

Qualifications

  • PhD, PharmD or equivalent in pharmacokinetics or related field.
  • Minimum 5 years’ experience, including postdoctoral fellowship; seniority aligned with experience.

Responsibilities

  • Oversee PK/PKPD analysis, modeling, and simulations for TOI oncology portfolio.
  • Lead preparation of CP program sections in regulatory documents and study reports.
  • Serve as CP expert on project teams and represent function in cross‑functional discussions.
  • Review PK/PD and bioanalytical data and manage vendor data transfers.
  • Contribute to study design and regulatory filings, including DDI and ADME studies.
  • Collaborate with Biostatistics, Data Management, Translational Pharmacology, and other groups to interpret PK data.

Skills

PK analysis
PK/PD modeling
Regulatory writing
Data analysis
Team leadership
External vendor mgmt

Education

PhD, PharmD or equivalent

Tools

PK software
Bioanalytical data handling

Job description

Taiho Oncology seeks a Sr. Manager, Clinical Pharmacology & Pharmacometrics to lead CP strategy across TOI-sponsored trials.

You will oversee PK/PKPD analyses, develop models, and contribute to regulatory submissions, working with cross‑functional teams to translate findings into actionable development plans. Ideal candidates have 5+ years in CP/PK, strong communication skills, and experience supervising external CROs.

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