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.

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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

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