Principal Scientist Toxicology

Proclinical is currently recruiting for a Principal Scientist of Toxicology with a leading biopharmaceutical company located in Seattle, WA. As the Toxicology Principal Scientist, you will be responsible for devising, implementing, and leading strategies to characterize the toxicologic properties of potential drug candidates, playing a critical role in advancing molecules through all stages of drug discovery and development.

Job Responsibilities:

• Serve as the Development Sciences/Toxicology Lead on multiple discovery and/or development teams, guiding characterization of safety properties of novel biologics to support decision-making and the advancement of preclinical programs and clinical drug candidates.
• Lead the design and conduct of exploratory, non-GLP, and GLP toxicology studies and the interpretation and reporting of results in the context of mechanisms of action or toxicity, dose- and exposure-response relationships, and the impact to predicted safety margins or therapeutic indices for putative drug candidates.
• Contribute to the design and conduct of related in vitro and in vivo studies (eg. pharmacology, pharmacokinetics) in collaboration with other team members, such as chemists, pharmacologists, bioanalytical scientists, and external contributors at contract research organizations.
• Independently formulate program toxicology strategy for and draft relevant sections of key documents supporting regulatory submissions (e.g. INDs).
• Interpret, summarize and present data to internal project teams, senior management, and external partners/organizations.

Skills and Requirements:

• PhD in toxicology or a related field and 10+ years of biotech/pharmaceutical drug discovery and development experience; Diplomate, American Board of Toxicology (or equivalent) preferred; title will be commensurate with experience.
• Regulatory experience supporting IND/CTA filings; experience in oncology drug development highly preferred and leading toxicology strategy for late-stage programs (e.g., pivotal trial design, NDA/MAA filings) a plus.
• Extensive experience and expertise devising toxicology strategy aligned with regulatory guidance and precedence, and in conducting toxicology studies for small molecule and biologics programs.
• Excellent critical thinking and scientific acumen, with a demonstrated ability to analyze, interpret, and clearly communicate (orally and in writing) complex toxicology study results and their impact to program and regulatory strategy

If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at (+1) 646-367-2764 or s.amark@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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