Sr. Principal Scientist, Pharmacometrics

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: Lead internal and external clinical pharmacokinetic (PK) and pharmacodynamics (PD) modeling and simulation activities. Oversees the design, conduct, and reporting of modeling and simulation analyses conducted by external Contract Research Organizations (CROs) in support of product registration of a small molecule therapeutic. Conducts internal 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. Will contribute to the preparation of an overall Clinical Pharmacology/Pharmacometrics Development Plan for NBI development compounds. _ Your Contributions (include, but are not limited to): Leads internal and external clinical PK and/or PK/PD modeling and simulation activities Develops novel and creative solutions to overcome issues/study obstacles Oversees the design, conduct, and reporting of modeling and simulation analyses conducted by external Contract Research Organizations (CROs) in support of regulatory submissions Provides expert consultation for PK/PD data from Phase 1/2 studies and application of quantitative decision-making to assist in the elucidation of dose- and exposure-response relationships to optimize subsequent clinical development Significantly contribute to the PK analysis, interpretation and reporting of PK results from clinical trials Expert resource for Nonclinical colleagues to lead/drive PK/PD modeling of discovery and development compounds in nonclinical test systems Development and implementation of industry leading, long-term Modeling and Simulation strategy for the organization Reports on results through written contributions to Clinical Study Reports Contributes to standards and best scientific practices development, maintenance and communication May lead publication of findings or is a major contributor to these processes Performs other duties as assigned Requirements: PhD, PharmD, or equivalent preferred in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a specific focus on PK and PK/PD modeling and simulation and 7+ years of drug development experience post PhD/PharmD OR MS and 13+ years of Pharmaceutical/Biotech industry experience Applies understanding of the team's place in the larger organization, and discusses changes, progress, and issues as they relate to other areas Maintains substantial knowledge of principles and theories and acts as a technical lead on various projects Leads the development of intellectual property May utilize working knowledge of other related disciplines to provide solutions to a wide range of difficult problems Ability to work as part of and lead multiple teams Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams Excellent communications, problem-solving, analytical thinking skills Sees broader picture and longer-term impact on division/company Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency Excellent project management, strong project leadership skills Ability to work in a cross functional team and matrix environment Expert knowledge in conduct and/or oversight of late-stage Modeling and Simulation activities, including conduct or oversight of small molecule population pharmacokinetic analyses In depth knowledge of all stages of clinical drug development, including the preparation of components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA-stage projects Demonstrated ability to independently design novel/highly complex studies to characterize PK/PD relationships of clinical development compounds Competent in the use of PK and PK/PD Modeling software tools including WinNonlin, NONMEM, S-Plus and SAS Significant expertise in preparing NDA/MAA summaries of population pharmacokinetic PK/PD analyses would be highly beneficial #LI-DM1 Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, 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 $156,900.00-$214,000.00. 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. We are a top place to work. Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma™ 2025. We were also named a Great Place to Work® Certified company. ©2025 Fortune Media IP Limited. All rights reserved. Used under license. OUR VALUES: PASSION: We are driven and love what we do. We are committed to our goals and to making a difference. INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up. COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed. INNOVATION: We seek and create optimal solutions. TENACITY: We do not quit. We adapt. We accomplish what others cannot. Come join our team during this exciting time of growth and opportunities!