Arrowhead Pharmaceuticals is a clinical stage, Nasdaq listed (ticker ARWR) company developing medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, our 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 specified gene, thereby affecting the production of a specific protein. Our RNAi-based therapeutics are at the leading edge with the potential to bring life changing treatments for patients.
Our Targeted RNAi Molecule (TRiMTM) platform utilizes ligand-mediated delivery and is designed to enable tissue-specific targeting while being structurally simple. The TRiM platform builds on more than a decade of work on targeted RNA delivery and offers several advantages including simplified manufacturing and reduced costs; multiple routes of administration; and potential for improved safety.
Our employees are nimble, science-driven, innovative professionals. A career at Arrowhead offers the opportunity to collaborate with top notch scientists to rapidly discover and develop RNAi-based therapeutics in a variety of indications to add to our growing pipeline. Research and development activities are located in Madison, WI. Our R&D group includes fully-integrated capabilities for chemistry, biology, toxicology and manufacturing.
Madison is an exciting and sophisticated city that includes state government, the flagship campus of the University of Wisconsin, and major research organizations.
Arrowhead is seeking a Director, Preclinical Toxicology to support the preclinical development of investigational drugs in the Arrowhead pipeline. The candidate will participate in multidisciplinary project teams in Madison, Wisconsin, and assist in optimizing development plans; design, conduct, and interpret nonclinical toxicology and investigational safety studies; and effectively communicate with regulatory agencies.
Key Duties and Responsibilities:
- Establish and maintain close working relationships with internal Arrowhead functional groups such as Research & Development, CMC, Regulatory Affairs, Clinical Development, and Program Management
- Provide toxicology support for planned US and international regulatory submissions, including authoring the nonclinical components of regulatory dossiers and communications (e.g., IND, CTA, IB, CAC, AP, NDA, and MAA) as well as responses to inquiries from regulatory agencies
- Participate in strategic planning for the nonclinical toxicology and investigational studies in support of clinical development programs
- Actively manage, and serve as Study Monitor as needed for the full spectrum of nonclinical studies supporting marketing authorization (General, Reproductive, Genetic, and Carcinogenicity toxicology studies; as well as Safety Pharmacology, Specialized toxicology, and investigative studies)
- Design and oversee non-GLP internal investigative studies in rodent and NHP company-managed or ‑affiliated animal facilities
- Identify, qualify, and monitor nonclinical CROs and vendors supporting various toxicology applications/activities
- DVM or PhD in pharmacology, toxicology or related scientific discipline with 4+ years directly relevant industry/CRO experience
- Proficient knowledge of general toxicology and related disciplines with expertise in one or more areas of specialization (e.g., cardiovascular, immunotoxicology, etc.)
- Familiarity with current regulatory toxicology guidelines, requirements, and standards (GLP, OECD, ICH, SEND, CTD, etc.) and the ability to develop nonclinical strategies that support expedited US and international clinical development efforts
- Experience in authoring nonclinical components of US and international regulatory dossiers
- Exceptional verbal and written communication skills; ability to communicate clearly and effectively with scientific colleagues and senior management
- Independent self-starter with the ability to work in a cross-functional team environment
- Highly motivated team player willing to contribute to growing biotech organization
- Strong Scientific reasoning ability in the proactive identification of potential issues, and the ability to draw conclusions and make appropriate decisions
- Board certification in toxicology (DABT)
Please submit a resume and cover letter to firstname.lastname@example.org.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the U.S. for a company.