Toxicology
Project Coordinator II, Toxicology
Office Location: Madison, WI
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 & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Project Coordinator will support the nonclinical development of investigational drugs in the Arrowhead pipeline by assisting Toxicology staff in technical writing of toxicology-related documentation, conduct of internal and external toxicology studies, and support tasks. The ideal candidate will have excellent writing skills and be detail-oriented, responsive, and collaborative.
Responsibilities
- Collaborate with Toxicology staff and cross-functional teams such as Regulatory Affairs, Medical Writing, Discovery Biology and Chemistry, DMPK, CMC, and Clinical Operations to prepare high-quality regulatory documentation for submission to global regulatory agencies
- Draft, edit, and/or QC nonclinical development documents, including but not limited to, nonclinical study reports, investigator’s brochures, integrated safety summaries, presentation materials, and IND and NDA applications
- Organize toxicology data, reports, datasets, and documents for regulatory submissions and track documents through review cycles
- Support internal exploratory toxicology studies with setup of the applicable systems, oversight of studies, and compilation of data
- Assist Toxicologists with startup and oversight of GLP toxicology studies
Requirements
- Bachelor’s Degree in Biology, Pharmacology/Toxicology, or related field
- 2+ years of pharmaceutical or scientific industry experience
- Excellent written/oral communication and strong time and project management skills
- Ability to independently and effectively operate in a fast-paced environment that requires collaboration, critical evaluation, and analytical judgment
- Demonstrated proficiency with Microsoft Office applications
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.