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: Neurocrine’s Drug Metabolism and Pharmacokinetics (DMPK) team is searching for an experienced pharmaceutical scientist to lead the application of absorption, distribution, metabolism, excretion (ADME) science to advance our portfolio. Working on cross-functional teams, our group applies in silico, in vitro, and in vivo approaches to mechanistically study the pharmacokinetics, absorption, and disposition of small molecules, biologics, peptides, gene therapies, and other complex modalities. You will serve as a technical leader within the DMPK department and participate in all stages of ADME assessment, from initial compound screening through IND and NDA regulatory submissions. This role will require engagement in experimental design and data interpretation to deliver the discovery and development portfolio of investigational targets and novel therapeutics. The candidate will represent DMPK on Research and Development teams and regularly interface with internal and external colleagues to ensure timely and accurate dissemination of ADME information. Your Contributions (include, but are not limited to): Acts as a DMPK representative on project teams providing scientific and strategic input Design, execute, and manage the conduct, interpretation, and reporting of in vitro drug metabolism data, in vivo PK studies, and PK-PD studies Prepare data summaries and presents results to peers, colleagues, project teams and leadership Oversee outsourcing partners of DMPK studies, ensuring partners adhere to contractual standards, within budget Provides expert level contribution in the preparation and review of regulatory submissions Integrate in vitro ADME, in vivo PK, and PK/PD endpoints with discovery biology data to define structure activity- and structure-property-relationships to guide optimization strategies Develop data visualization strategies to ensure consistent data interpretation across project teams to drive portfolio decisions Aid in ADME knowledge management Effectively partner to apply innovative mechanistic modeling approaches to translate and predict human PK, inform clinical plans, and support compound registration Will provide mentorship to and frequently supervise the day-to-day work of less experienced team members Requirements: BS/BA in biology, chemistry, or related science field and 12+ years of hands-on experience with automation, tissue culture, LC MS/MS. Strong background in DMPK screening models, particularly permeability and transporter models. Experience acting as a DMPK representative on discovery teams. Experience in an ADME laboratory is preferred OR MS/MA in biology, chemistry, or related science field and 10+ years of similar experience noted above OR PhD or equivalent and 4+ years of relevant experience; may include postdoc experience Demonstrated results/experience in working with interdisciplinary teams Working knowledge of the principles of ADME and pharmacokinetics Solid understanding of organic/medicinal chemistry Strong communication skills (written and verbal) Ability to lead, guide and influence teams in decision making Proficient in analyzing and visualizing multi-dimensional scientific data Excellent communication, problem-solving, analytical thinking skills Excellent project management skills Ability to mentor and direct the day-to-day work of less experienced team members Expertise acting as a DMPK representative on discovery teams Ability to work as part of and lead multiple teams Evaluate and apply innovative PK and PK/PD approaches to predict human PK, using modeling to help generate hypotheses, design studies, inform clinical plans, and support registration Experience with mathematical modeling workflows using relevant software such as R, Matlab, Python, SimCyp, WinNonLin, SimulationsPlus, Monolix, etc. Proficient in scripting/programming in one or more of the following languages: Python, C/C++, R Build a strong external network (e.g. academia, consortia) and keep up to date with emerging literature and science in the area. Sees broader picture, impact on multiple programs, teams and/or departments Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
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