Senior Scientist / Principal Scientist, Clinical Pharmacology

The Position

This role provides clinical pharmacology and pharmacometrics leadership for assigned development programs and may be based in San Diego, CA or Madison, WI. The position is responsible for contributing to clinical trial design, authoring key protocol and regulatory sections, and performing hands-on PK/PD analyses to guide dose selection and program strategy. It oversees the preparation and authorization of PK analysis reports, CSR content, and clinical pharmacology components of global regulatory submissions

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