Associate Director/Director, Clinical PK/PD at Arrowhead Research in San Diego, CA

Arrowhead seeks an Associate Director/Director, Clinical PK/PD to join its Clinical Pharmacology team. This individual will report into Arrowhead’s VP, Clinical Pharmacology/DMPK. This position has the option of being based in our corporate headquarters in Pasadena, CA or one of our R&D facilities in San Diego, CA or Madison, WI.

Responsibilities

• Conduct hands-on analysis of clinical or translational PK/PD data, and authorize PK clinical study reports
• Provide PK/PD Modeling & Simulations to support dosing strategies for clinical programs; contribute to clinical pharmacology strategy and planning for clinical programs
• Ensure timely and accurate communication of study results and interpretation with appropriate internal drug development teams
• Ensure high quality of documentation compatible with global regulatory submission requirements
• Maintain a current understanding of small and large molecule PK/pharmacometrics literature and methodology including RNAi therapeutics, and the state-of-art in Model-Informed Drug Development (MIDD)

Requirements:

• PhD (or work-place equivalent) in pharmacokinetics, pharmacology or pharmaceutical science
• 10+ years of pharmaceutical industry experience
• Industrial experience in clinical NCA PK analysis and data reporting using Phoenix WinNonlin and SAS program with familiarity of authorizing PK clinical study report (PK CSR) in submission standard
• Knowledge of FDA/ICH guidance related to NCA and PopPK analysis is required

Preferred:

• Industry experience in clinical-stage drug development is preferred
• Skills in population PK, PK/PD modeling using NONMEM or NLME is highly desired, while PBPK modeling experience is a plus