Clinical Pharmacologist

Responsibilities

• Design and analyze pharmacokinetic/pharmacodynamic studies for early clinical development.
• Develop population PK and exposure-response models using NONMEM and R.
• Provide dose selection recommendations for Phase I/II clinical trials.
• Author clinical pharmacology sections for regulatory submissions (IND, NDA, MAA).
• Collaborate with clinical and preclinical teams on drug-drug interaction assessments.

Requirements

• PhD or PharmD in Clinical Pharmacology, Pharmacokinetics, or Pharmaceutical Sciences.
• 5-8 years of experience in clinical pharmacology within the pharma/biotech industry.
• Expertise in population PK modeling, PBPK, and exposure-response analyses.
• Proficiency in NONMEM, Phoenix WinNonlin, and R.
• Strong publication record and regulatory interaction experience.