Arrowhead Pharmaceuticals, Inc. is a Nasdaq listed (ARWR), Russell 3000 company that develops medicines to 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’s dynamic and innovative environment offers our employees the opportunity to advance revolutionary treatments for serious and intractable diseases. Our employees are smart, creative professionals who work collaboratively to meet our business and scientific challenges. Arrowhead’s R&D facility is located in the Research Park in Madison, WI.
We seek a preclinical toxicologist to support the preclinical development of investigational drugs in the Arrowhead pipeline. The individual in this position will participate in multidisciplinary research/discovery project teams in Madison and assist in the design, conduct, and interpretation of results from nonclinical toxicology and investigational safety studies as well as assist in the review of study reports from GLP safety studies and preparation of regulatory submissions.
Key Duties and Responsibilities:
- Establish and maintain close working relationships with internal Arrowhead functional groups such as CMC, Biology, Laboratory Animal Resources, Pathology, DMPK, Regulatory Affairs and Program Management.
- In conjunction with the research/discovery project teams, design and oversee the conduct of non-GLP investigative studies in internal or company-affiliated animal facilities in support of clinical development programs.
- Proactively coordinate with the research/discovery teams and functional groups to plan and oversee resourcing for internal investigative safety studies.
- Review and interpret study data/results and prepare appropriate study reports for all internal investigative safety studies.
- Maintain and organize study information and records for internal investigative safety studies.
- Contribute to US and international regulatory submissions, including the nonclinical components of regulatory documents, dossiers and communications (e.g., IND, CTA, IB, NDA, and MAA).
- Participate in strategy discussions for the nonclinical toxicology and investigational studies in support of clinical development programs.
- Serve as Study Monitor (including the review and interpretation of study data/results) for outsourced preclinical studies as needed.
- BS or higher in toxicology, pharmacology, biology, or related scientific discipline.
- Minimum of 2 years of experience in a biopharmaceutical/biotech company or contract research organization.
- Competent knowledge of and ability to use Microsoft Word, Excel, and PowerPoint.
- Capability to effectively manage technical details.
- Excellent 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 matrixed, cross-functional, team-based drug discovery/development environment. Highly motivated team player willing to contribute to a growing biotech organization.
- Highly organized, detailed-oriented self-starter who endeavors to anticipate and resolve problems and seeks opportunities to grow in their role and responsibilities at Arrowhead.
- Knowledge of general toxicology and related disciplines.
- Working knowledge of Good Laboratory Practice regulations and familiarity with regulatory guidance documents (FDA, ICH, OECD).
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.