Director/Sr. Director, Clinical Pharmacology
2 weeks ago
The Position
Arrowhead Pharmaceuticals is seeking an experienced Clinical Pharmacologist to join our team.
Responsibilities
* 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
Requirements:
* 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
Preferred:
* Skills in population PK and PD modeling
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