Scientific Director, Pharmaceutical Development Analytics

About the role

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, 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 more than 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 , Facebook and YouTube . ( *in collaboration with AbbVie ) The Scientific Director, CMC Quantitative Sciences is a senior technical individual contributor responsible for designing and advancing data-driven development and lifecycle management initiatives for drug products, including knowledge management, through application of advanced statistical analysis, experimental design, and quantitative modeling. Embedded within Pharmaceutical Development, this role serves as the portfolio-level statistical authority supporting drug product development programs from post-Proof of Concept through regulatory submission and the commercial lifecycle. In addition to serving as a quantitative authority, this role actively supports formulation and process development strategy by integrating statistical and mechanistic understanding of product design (at first principles-level) to optimize formulations for performance, stability and manufacturability, and strengthen process robustness. The Director partners cross-functionally with Pharmaceutical & Analytical Development, Quality, Regulatory CMC, and Commercial Manufacturing & Supply Chain to ensure that development and manufacturing decisions are supported by rigorous statistical analysis and defensible interpretation of CMC data. This role provides technical leadership across multiple development programs, strengthening process understanding, enabling robust control strategies, and improving the quality and regulatory defensibility of CMC submissions. While embedded in Pharmaceutical Development, the position influences programs spanning late-stage development through commercial lifecycle management and serves as a technical authority and mentor for quantitative approaches across CMC functions. _ Your Contributions (include, but are not limited to): Pharmaceutical Development (CMC) Owns drug product design and development strategy Generates, maintains and leverages process understanding and development data Informs control strategy for regulatory submission and hands-off to commercial Commercial Manufacturing Owns routine manufacturing execution and maintains continuity of supply to the market Owns site-level monitoring and operational performance Owns CPI/CPV strategy, including design, oversight of execution, monitoring and reporting Scientific Director, Pharmaceutical Development Quantitative Sciences (This Role) Provides advanced statistical analysis and modeling expertise across CMC programs Translates complex development and manufacturing data into actionable technical insights Ensures statistical rigor and regulatory defensibility of CMC data packages Serves as a technical authority for statistical interpretation across lifecycle stages Supports formulation and process development strategies through data-driven insights and mechanistic interpretation Supports troubleshooting efforts and root-cause investigations as needed on both the formulation and process development fronts for development and commercial assets Complex Data Interpretation Apply multivariate tools to support identification of CMAs, CPPs, and design space boundaries Serve as a technical authority for complex data interpretation across CMC programs Provide statistical guidance for investigations involving process variability. Support root cause analysis of complex development or manufacturing trends Integrate datasets across development, analytical, and manufacturing functions to generate actionable insight Translate experimental data into formulation and process understanding, including identification of critical material attributes, excipient functionality, and process sensitivities Support development teams in interpreting DoE outcomes to refine formulations and unit operations (e.g., granulation, blending, compression, coating) Formulation & Process Development Support

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