Director/Sr. Director, Clinical Pharmacology & Pharmacometrics

at  Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

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

• 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 member