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Neurocrine Biosciences

Principal Scientist, DMPK

Neurocrine Biosciences, San Diego, California, United States, 92189


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, but few options.What We Do:Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. 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, 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.About the Role:Represents DMPK and plays a key role in the multidisciplinary discovery and development team to advancement Neurocrine's medicines including small molecules, biologics, peptides, and gene therapies. Participate in all stages of ADME assessments, from initial compound screening through to IND and NDA regulatory submissions. Working with Research, Bioanalytical and Clinical Pharmacology subject matter experts, provides scientific leadership to ensure that clinical candidates with acceptable drug development characteristics are identified and appropriately characterized. Represents Preclinical Development on Research and Development teams and regularly interfaces with internal and external colleagues to ensure timely and accurate dissemination of ADME findings. Contribute to long term strategic planning to enable the growth and enhance productivity of the DMPK group.Your Contributions (include, but are not limited to):Acts as a DMPK representative on participating teams and providing scientific and strategic input.Design, execute and manage the conduct, interpretation, and reporting of PK, PK-PD and drug metabolism studies.Integrate ADME, PK and PK/PD endpoints with discovery biology data to define structure activity- and structure-property-relationships to guide optimization strategies.Prepare data summaries and presents results to peers, colleagues, project team and leadership teams.Oversees outsourcing partners of DMPK studies, ensures partners adhere to contractual standards, within budget.Provides expert level contribution in the preparation and review of regulatory submissions.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 ORMS/MA in biology, chemistry, or related science field and 10+ years of similar experience noted above ORPhD or equivalent and 4+ years of relevant experience; may include postdoc experience.Expertise acting as a DMPK representative on discovery and development teams.Expertise and working knowledge of pharmacokinetics of small and large molecules, drug metabolism, in vitro enzyme kinetics and LC/MS bioanalytical methodology.Evaluate and apply innovative PK and PK/PD approaches to predict human PK, using modeling as a tool to help generate hypotheses, design studies, inform clinical plans, and support registration.Excellent written and verbal communication skills and demonstrated ability to lead, guide and influence teams in decision making.Expert knowledge of scientific principles, methods and techniques.Ability to balance multiple projects and handle competing responsibilities.Collaborative team behaviors and aspiration to build and sustain relationships with R&D customers and the wider scientific community.Assimilates data and research findings outside of Neurocrine for application to new scientific projects.Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas.May develop an understanding of other areas and related dependencies.Ability to work as part of and lead multiple teams.Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams.Excellent communications, problem-solving, analytical thinking skills.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.Excellent project management skills.Ability to mentor and direct the day-to-day work of less experienced team members.Neurocrine Biosciences is an EEO/AA/Disability/Vets employer. We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.

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