NEUROCRINE BIOSCIENCES

We are seeking a skilled and qualified industrial scientist who has experience in planning and executing MIDD approaches to join us as a Principal Scientist.. You will work with experienced pharmacometricians, Preclinical Pharmacokinetics, Drug Metabolism, Toxicology, and Clinical Pharmacology colleagues to provide inputs to overall product development plans and to address research and development objectives and issues. Oversees the design, conduct, and reporting of modeling and simulation analyses conducted by external Contract Research Organizations (CROs) in support of regulatory submissions. MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a specific focus on PK and PK/PD modeling and simulation and 10+ years of Pharmaceutical/Biotech industry experience in conduct and/or oversight of late-stage Modeling and Simulation activities, including conduct or oversight of small molecule population pharmacokinetic analyses.. PharmD or PhD or equivalent preferred and 4+ years of relevant experience; may include postdoc experience

principal scientist

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 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, endocrine and psychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson’s disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple 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. *in collaboration with AbbVie About The Role The Pharmacometrics Group applies a range of model informed drug development (MIDD) approaches to support early and late-stage development of small and large molecules. We are seeking a skilled and qualified industrial scientist who has experience in planning and executing MIDD approaches to join us as a Principal Scientist. In this role, you will be responsible for the recommendation and implementation of pharmacometrics methodologies, contributes to internal and external clinical pharmacokinetic (PK) and pharmacodynamics (PD) modeling and simulation activities. Conducts PK/PD modelling and simulation in support of early stage programs or internal decision-making of late-stage programs. Will present modelling and simulation analyses to internal project teams and may present to external colleagues or regulatory agencies. You will work with experienced pharmacometricians, Preclinical Pharmacokinetics, Drug Metabolism, Toxicology, and Clinical Pharmacology colleagues to provide inputs to overall product development plans and to address research and development objectives and issues _ Your Contributions (include, But Are Not Limited To) <ul><li>Represent the Pharmacometrics Group in multi-function matrix teams and serve as a subject matter expert</li><li>Lead the planning, execution, and timely delivery of MIDD and Pharmacometrics strategies and documents to support dose selection, clinical trial design and regulatory submissions on assigned programs</li><li>Oversees the design, conduct, and reporting of modeling and simulation analyses conducted by external Contract Research Organizations (CROs) in support of regulatory submissions</li><li>Independently conducts PK/PD analyses of data from Phase 1/2 studies and application of quantitative decision-making to assist in the characterization of population PK, dose- and exposure-response relationships to optimize subsequent clinical development</li><li>Communicate and interpret modeling results to project teams. Accountable for ensuring appropriate design and implementation of pharmacometrics plans</li><li>Collaborate with other colleagues to review and validate M&S outputs such as datasets and modeling programs</li><li>Prepare posters, publications, presentations for internal and external conferences</li><li>Performs other duties as assigned </li></ul>Requirements <ul><li>MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a specific focus on PK and PK/PD modeling and simulation and 10+ years of Pharmaceutical/Biotech industry experience in conduct and/or oversight of late-stage Modeling and Simulation activities, including conduct or oversight of small molecule population pharmacokinetic analyses. Experience in the preparation of components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA-stage projects OR</li><li>PharmD or PhD or equivalent preferred and 4+ years of relevant experience; may include postdoc experience</li><li>Demonstrated foundation of scientific knowledge (e.g., basic pharmacokinetic/pharmacodynamic [PK/PD] and pharmacology concepts) and technical pharmacometrics skills including but not limited to nonlinear mixed effect modeling, mechanistic PK/PD, physiologically-based pharmacokinetic (PBPK), quantitative systems pharmacology (QSP) modeling and clinical trial simulations</li><li>Competent in using modeling tools for population PK, PD analysis (e.g., NONMEM, Monolix, Simcyp, R packages for nonlinear mixed-effects modeling)</li><li>Proactive, innovative, with good problem-solving skills</li><li>Able to take different pharmacometrics assignments and deliver the results promptly</li><li>Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to cross-functional audiences</li><li>A critical thinker and quick learner with high engagement</li><li>Demonstrated experience and track record in clinical-stage drug development is a plus</li><li>Assimilates data and research findings outside of Neurocrine for application to new scientific projects</li><li>Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas</li><li>May develop an understanding of other areas and related dependencies</li><li>Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools</li><li>Ability to work as part of and lead multiple teams</li><li>Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams</li><li>Excellent computer skills</li><li>Excellent communications, problem-solving, analytical thinking skills</li><li>Sees broader picture, impact on multiple programs, teams and/or departments</li><li>Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency</li><li>Excellent project management skills</li><li>Ability to work in a cross functional team and matrix environment </li></ul>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. _ The annual base salary we reasonably expect to pay is $125,700.00-$182,250.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

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