Scientist II, Toxicology

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Requirements:

• Ph.D. (or equivalent) degree in Toxicology, Pharmacology, or a related discipline with 2 + years or a MS and 6 + years in the biopharmaceutical industry, including experience with toxicology testing across multiple modalities (ie, oligonucleotides, biologics, small molecules).
• Current or previous study director experience, with expertise in providing toxicology support on cross-functional development and discovery teams throughout various stages of development
• Strong knowledge of GLP regulations.
• Knowledge of biochemical and mechanistic toxicology, and ability to design and interpret studies exploring mechanisms of toxicology involving biochemical, functional, and/or structural endpoints.
• Knowledge of human risk assessment, as it pertains to drug development.
• Strong scientific and leadership skills, with effective written and oral communication abilities, particularly in crafting clear and accurate documents for global regulatory submissions and health authority responses.
• Ability to effectively communicate and interact with co-workers at all levels and to work independently and on teams.
• Strong understanding of ICH, FDA and EMA guidance related to nonclinical assessment of drug candidates.

Responsibilities:

• Serve as Study Monitor for non-GLP and GLP studies conducted at CROs while ensuring compliance with Good Laboratory Practice (GLP) regulations and all company/department Standard Operating Procedures (SOPs).
• Communicate toxicology study findings to Toxicology management and program teams in a timely manner.
• Ensure internal and external studies are conducted in strict accordance with protocols and aligned with overall program timelines.
• Contribute to the design and implementation of the toxicology strategy for programs in various stages of development.
• Actively participate in the critical review of submission documents such as CTDs for INDs and NDAs, Investigator Brochures, PIPs, briefing books, etc. to support clinical trials and drug registration.
• Serve as Toxicology subject matter expert for multidisciplinary investigative efforts to address/resolve program-related toxicology issues/concerns.
• Review and edit toxicology study protocols and reports with regard to scientific design, interpretation and regulatory compliance (GLP, animal welfare and safety).
• Provide scientific collaboration within the Product Development team and across discovery groups to help evaluate and nominate drug candidates with minimal or predictable toxicity profiles.
• Actively participate in Product Development scientific discussions for compounds across the portfolio.
• Evaluate and apply new scientific methodologies in order to maintain scientific excellence, increase productivity, meet our research and drug registration needs, and minimize or resolve toxicity-based issues.
• Dedication to an atmosphere of scientific excellence, open communication, and creativity to help achieve company and departmental goals.