Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com , and follow the company on LinkedIn , X and Facebook . (*in collaboration with AbbVie) About the Role: Responsible for the conduct of in-house in vivo, in vitro and ex vivo drug safety evaluation studies (toxicology and safety pharmacology) and/or pharmacokinetic studies to support drug discovery and development activities. Collaborates with Research, CMC and other departments on projects pertaining to drug safety and pharmacokinetic studies. Provides data generation, analysis, and interpretation for archiving according to best practices or standard operating procedures. Works as part of a multidisciplinary team to support the conduct of non-GLP and/or GLP-compliant preclinical studies. May contribute to and/or prepare final study reports and support regulatory submissions. Your Contributions (include, but are not limited to): Work collaboratively with other scientists and colleagues as part of multidisciplinary project teams to ensure tasks are conducted accurately and meet intended scientific objectives. Plan, write study protocols, and conduct controlled experiments to characterize toxicological and PK properties of new investigational drugs in accordance to best practices/SOPs. Prepare dose formulations and other reagents as instructed. Perform test article dosing (IP, IM, SQ, IC, PO), non-terminal biological sample (e.g., blood, CSF, urine, feces, tissues) collection, necropsies, and terminal sample collections. Document in vivo study data including but not limited to clinical observations, body weights, food consumption, and environmental findings. Perform cell culture, in vitro test article administration, sample collection/processing, and biochemical assays. Document in vitro study data including but not limited to culture method, cell viability, and biochemical assay findings. Perform ex vivo methods such as DNA/RNA/miRNA/Protein isolation, PCR, NGS, traditional and automated western blot, and immunoassay (e.g., ELISA, Luminex); and related data recording and analysis. Perform histopathology (e.g., tissue/cell processing, embedding, microtomy, H&E and special stains, in situ hybridization, immunohisto- and immunocytochemistry, imaging/analysis) and related documentation. Collect, analyze, and communicate results as well as assist in preparing reports. Attend professional meetings, trainings and/or workshops to gain vital insight into the global toxicological sciences' landscape and/or present scientific information; and publish in peer-reviewed journals. Performs other duties as assigned. Requirements: Bachelor's degree in life sciences or related field and 2+ years experience in CRO and/or pharmaceutical industry in the conduct of small molecule Toxicology/Safety Pharmacology programs. Experience in managing preclinical CROs. Experience in the conduct of in vitro or in vivo toxicology techniques to support investigative toxicology or pharmacokinetic activities, including dose preparation and dosing of animals. Experience with conduct of pharmacokinetic and metabolism studies is highly desirable. Experience with micro-sampling techniques is a plus. MS/MA degree in Toxicology or related field and some relevant experience preferred. Working knowledge of the conduct of in vitro or in vivo toxicology techniques to support investigative toxicology or pharmacokinetic activities, including dose preparation and dosing of animals; pharmacokinetic and metabolism studies and micro-sampling techniques. Effective report writing and oral presentation skills. Must be able to build excellent working relationships & maintain confidentiality regarding intellectual property and proprietary endeavors of the company. Understanding of SOPs, IACUC requirements, NIH guidelines, CDER guidance, ICH guidance, OECD guidelines, and related regulations. Ability to determine project requirements, study designs, and to perform data analysis of reports from studies conducted in-house. Recognizes fundamental anomalies in data points and identifies issues in experiments/processes. Begins to understand how to think outside of the technical process and consider the impact decisions will have on the broader scientific goals. Strong knowledge of one scientific discipline. Good knowledge of scientific principles, methods and techniques. Good knowledge and demonstrated ability working with a variety of laboratory equipment/tools. Ability to work as part of a team. Strong computer skills. Good communications, problem-solving, analytical thinking skills. Detail oriented. Ability to meet deadlines. Good project management skills.
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