Clinical Pharmacology Leader
4 weeks ago
Arrowhead Pharmaceuticals is a clinical-stage biopharmaceutical company that develops innovative medicines to treat intractable diseases. Our RNA interference (RNAi) technology platform enables us to silence genes that cause diseases, leading to rapid, deep, and durable knockdown of target genes.
We are seeking an experienced Clinical Pharmacologist to lead our Clinical Pharmacology/Pharmacometrics function for multiple programs in Phase 1-3 development. The successful candidate will contribute to clinical protocol design and execution, analyze data, and prepare clinical study reports.
The ideal candidate will have a PhD in pharmacokinetics, pharmacology, or pharmaceutical science, with a track record of clinical pharmacology program leadership and 7+ years of pharmaceutical/Biotech industry experience. They will have established knowledge of drug development from Pre-INA to NDA/BLA and be able to apply scientific principles to complex situations.
The Clinical Pharmacologist will provide leadership expertise and mentor junior team members. They will also be responsible for maintaining a current understanding of field literature for oligonucleotide therapeutics and Model-Informed Drug Development (MIDD). Additionally, they will provide PK/PD modeling & simulations to support dosing strategies for clinical programs.
Arrowhead Pharmaceuticals offers a competitive salary and an excellent benefit package. The company is headquartered in Pasadena, CA, with research and development teams in Madison, WI, and San Diego, CA.
Responsibilities:
- Lead the function of Clinical Pharmacology/Pharmacometrics for multiple programs in Phase 1-3 development
- Contribute to clinical protocol 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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