Senior Scientist / Principal Scientist, Clinical Pharmacology

Responsibilities

• Provide Clinical Pharmacology and pharmacometrics leadership for designated programs, contribute to design of clinical trial protocols and relevant sections in Investigational Brochure (IB), conduct hands-on analysis of clinical or translational PKPD data, support dosing strategies and clinical pharmacology planning.
• Authorize clinical PK analysis reports and relevant sections in the Clinical Study Report (CSR).
• Provide high quality documentation of clinical pharmacology analysis compatible with global regulatory submission requirements. Authorize clinical pharmacology modules of CTD to support global filings of marketing application.
• Provide timely communication of analysis results and interpretation with drug development teams.
• Maintain a current understanding of clinical pharmacology literature and regulatory guidance for oligonucleotide/RNAi therapeutics.

Requirements

• PhD or PharmD in the field of pharmacokinetics, pharmacology or pharmaceutical science, 3 years of pharmaceutical industry experience in clinical-stage drug development.
• Good understanding of FDA/EMA/ICH guidance related to clinical pharmacology.
• Established experience in clinical NCA PK analysis and data reporting using Phoenix WinNonlin with familiarity of authorizing PK study report.
• Proficiency in NONMEM and skill of population PKPD modeling is essential.

Preferred

• PBPK/PD modeling

California pay range

California pay range: $120,000 USD - $170,000 USD