Director/Sr. Director, Clinical Pharmacology - San Diego, United States - Arrowhead Pharmaceuticals, Inc.

Description

• Lead the function of Clinical Pharmacology/Pharmacometrics for multiple programs in Phase 1-3 development
• Contribute to clinical protocols design and execution; analyze data and prepare clinical study reports
• Participate in regulatory interactions with global Health Authorities and prepare documents with submission standards
• Maintain a current understanding of field literature for oligonucleotide therapeutics, and Model-Informed Drug Development (MIDD)
• Provide PK/PD Modeling & Simulations to support dosing strategies for clinical programs
• Provide leadership expertise and mentor junior team members

• PhD or equivalent in pharmacokinetics, pharmacology or pharmaceutical science
• Track records in clinical pharmacology program leadership with 7+ years of pharmaceutical/Biotech industry experience
• Established knowledge of drug development from Pre-INA to NDA/BLA
• Ability to apply scientific principles to complex situations and provide effective solutions
• Strong verbal communication and document writing skills with clarity of thinking
• Proficiency in non-compartmental analysis of clinical PK data

• Skills in population PK and PD modeling