Senior Pharmacometric Director — Clinical PK/PD & DMPK

Summit Therapeutics, Inc.

Palo Alto (CA)

On-site

USD 174,000 - 204,000

Full time

6 days ago
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Job summary

Summit Therapeutics Inc. is seeking an Associate Director, Clinical Pharmacology & DMPK to lead pharmacometrics, PK/PD, MBMA, and exposure–response analyses for the company's oncology assets.

You will drive model-informed drug development strategies and support dose optimization and regulatory submissions. In this role, you will collaborate with Clinical Development, Biostatistics, Data Management, and Regulatory Affairs, oversee external vendors, and contribute scientifically to program

Qualifications

  • PhD or PharmD with 3+ years in pharma/biotech.
  • Hands-on quantitative modeling with pharmacometrics tools.
  • Experience drafting pharmacometric analyses for regulatory submissions.
  • Strong scientific writing, communication, and project management.

Responsibilities

  • Serve as a pharmacometrics SME on cross-functional teams.
  • Design, execute, and report NCA, PopPK, PK/PD, MBMA, and exposure–response analyses.
  • Develop quantitative models to support trial design and decisions.
  • Oversight of external pharmacometrics vendors and consultants.
  • Contribute to regulatory submissions and health authority responses.
  • Perform data processing, modeling, simulations, and visualization.

Skills

Pharmacometrics
NONMEM/PsN
R
Phoenix WinNonlin
Cross-functional collaboration

Education

PhD
PharmD
MS in related field

Tools

NONMEM
PsN
R
Phoenix WinNonlin

Job description

Summit Therapeutics Inc. is seeking an Associate Director, Clinical Pharmacology & DMPK to lead pharmacometrics, PK/PD, MBMA, and exposure–response analyses for the company's oncology assets.

You will drive model-informed drug development strategies and support dose optimization and regulatory submissions. In this role, you will collaborate with Clinical Development, Biostatistics, Data Management, and Regulatory Affairs, oversee external vendors, and contribute scientifically to program

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