Scientific Director, Pharmaceutical Development Data Sciences Analytics / CMC Statistics

Scientific Director, Pharmaceutical Development Analytics 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 Scientific Director, Pharmaceutical Development Analytics is a senior technical individual contributor and portfolio-level quantitative expert responsible for advancing data-driven drug product development across the CMC lifecycle. Embedded within Manufacturing, Science & Technology (MSAT), this role applies advanced statistics, experimental design, quantitative modeling, and mechanistic understanding to strengthen formulation and process development, process characterization, control strategies, and regulatory submissions. The Scientific Director partners across Technical Operations, Quality, Regulatory CMC, Commercial Manufacturing, and Supply Chain to transform complex development and manufacturing data into actionable scientific insights that improve product performance, process robustness, and regulatory defensibility. Your Contributions (include, but are not limited to):Scientific & Technical Leadership Serve as the portfolio-level statistical and quantitative sciences expert supporting drug product development from post-Proof of Concept through commercialization Provide technical leadership across multiple CMC programs to strengthen process understanding, lifecycle knowledge management, and data-driven decision making Mentor scientists and promote best practices in statistical thinking, experimental design, and quantitative analysis Development Analytics & Modeling Design and apply advanced statistical methods, including Design of Experiments (DoE), multivariate analysis, response surface modeling, and process variability analysis Integrate development, analytical, and manufacturing data to identify critical material attributes (CMAs), critical process parameters (CPPs), process sensitivities, and design space Translate complex datasets into scientifically sound recommendations that improve formulation performance, manufacturability, and product quality Formulation & Process Development Partner with Pharmaceutical Development scientists to optimize formulations and manufacturing processes using data-driven and mechanistic approaches Support process characterization, scale-up, robustness assessments, risk analyses, troubleshooting, and root-cause investigations Guide development of robust control strategies by linking material attributes, process parameters, and product performance Regulatory & Lifecycle Support Serve as the quantitative lead supporting CMC regulatory submissions (IND, CTA, NDA, BLA, MAA) and lifecycle management activities Ensure statistical methodologies align with regulatory expectations and ICH guidelines (Q8, Q9, Q10, Q14) Support regulatory responses by providing clear, scientifically defensible interpretation of CMC data

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 $163,400.00-$223,000.00. 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 35% 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.