Arrowhead Pharmaceuticals, Inc. is a Nasdaq listed (ARWR) company that develops medicines to treat intractable diseases by silencing the causative genes. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference (RNAi) mechanism to induce rapid, deep and durable knockdown of target genes. 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’s dynamic and innovative environment offers our employees the opportunity to advance revolutionary treatments for serious and intractable diseases. Our employees are creative and dedicated professionals who work collaboratively to our meet business and scientific challenges. Arrowhead’s R&D facility is located in the Research Park in Madison, WI.
Arrowhead seeks a Toxicologist to join a growing group of dedicated professionals responsible for establishing the nonclinical safety profiles of our promising investigational drugs. Reporting to the Executive Director, Toxicology, the candidate will participate on multidisciplinary project teams in Madison, Wisconsin, where s/he will assist in optimizing development plans; design, conduct, and interpret nonclinical toxicology and investigational safety studies; and effectively communicate with worldwide regulatory agencies to bring our drugs to patients as quickly as possible. This is an ideal position for an independent individual with a strong background in preclinical toxicology who enjoys working in a team-oriented and highly cross-disciplinary environment. This position also offers opportunities to help build a highly efficient nonclinical development group with a clinical-stage company with a promising pipeline. Specific responsibilities include:
- Establishing and maintaining close working relationships with internal Arrowhead functional groups such as Pharmaceutical Development and 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 (eg, IND, CTA, IB, CAC, AP, NDA, MAA, etc) as well as responses to inquiries from regulatory agencies.
- Active participation in strategy discussions 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+ yrs directly relevant industry/CRO experience. Board certification (DABT) is a plus.
- 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.
- Independent self-starter with the ability to work in a matrixed, cross-functional, team-based drug discovery/development environment. Highly motivated team player willing to contribute to a growing biotech organization.
- Strong scientific reasoning ability in the proactive identification of potential issues, and the ability to draw conclusions and make appropriate decisions.
- Exceptional verbal and written communication skills; ability to communicate clearly and effectively with scientific colleagues and senior management.
Competitive salary and excellent benefits package
All applicants must have authorization to work for Arrowhead in the U.S.
Please send resumes to email@example.com. Include a cover letter that highlights your qualifications and matches our requirements.