Scientific Director, Pharmaceutical Development Analytics

About the Role The Scientific Director, CMC Quantitative Sciences is a senior technical individual contributor who designs and advances data‑driven development and lifecycle management initiatives for drug products. The director serves as the portfolio‑level statistical authority for drug product development programs from post‑Proof of Concept through regulatory submission and the commercial lifecycle. The role collaborates 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. Key Contributions 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 hand‑off to commercial Owns routine manufacturing execution and maintains continuity of supply to the market Owns site‑level monitoring and operational performance (CPI/CPV strategy, design, oversight, 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 Supports formulation and process development strategies through data‑driven insights and mechanistic interpretation Supports troubleshooting efforts and root‑cause investigations on both the formulation and process development fronts for development and commercial assets Applies multivariate tools to identify CMAs, CPPs, and design space boundaries Provides statistical guidance for investigations involving process variability and rootcause analysis of complex development or manufacturing trends Integrates datasets across development, analytical, and manufacturing functions to generate actionable insight Translates experimental data into formulation and process understanding, including identification of critical material attributes, excipient functionality, and process sensitivities Supports development teams in interpreting DoE outcomes to refine formulations and unit operations (granulation, blending, compression, coating) Formulation & Process Development Support Partners with Pharmaceutical Development scientists to design and optimize formulations using structured experimental approaches (DoE, mixture designs, response surface methods) Provides quantitative and mechanistic input into selection of excipients, formulation composition, and process parameters Supports development and scale‑up of key unit operations (fluid bed granulation, roller compaction, blending, tableting, coating) through data‑driven modeling and risk assessment Guides process characterization strategies (definition of parameter ranges, interaction effects, and scale dependencies) Contributes to development of robust manufacturing processes by linking material attributes, process parameters, and product performance Supports assessment of formulation and process robustness, including sensitivity analyses and failure mode identification Regulatory Submission Support Primary statistical authority supporting CMC regulatory submissions (NDA, BLA, MAA) Ensures statistical methodologies used in development and validation are regulatory defensible and aligned with ICH guidelines (Q8, Q9, Q10, Q14) Provides statistical interpretation for process validation strategies and control strategy justification Supports responses to regulatory questions related to CMC data analysis and statistical methodology Contributes to justification of formulation composition, process design, and design space within regulatory filings Capability Building Strengthens quantitative capabilities across Pharmaceutical Development Drives adoption of modern data science and modeling approaches that improve development efficiency and process understanding Establishes best practices for experimental design and statistical analysis in development programs Mentors scientists on statistical thinking and interpretation of experimental results Promotes integration of statistical and formulation/process science to enable more predictive and efficient development approaches What the Role Does NOT Include Direct management or formal supervision of staff Own routine manufacturing execution or site‑level operational performance Serve as program CMC functional area lead or make final operational, business, or budgetary decisions for CMC programs Manage headcount, administrative processes, or team performance evaluations Replace hands‑on experimental or process work performed by development teams Requirements PhD, PharmD, or MS in Statistics, Chemical Engineering, Pharmaceutical Sciences, or related quantitative discipline 12-15+ years of experience applying statistical analysis to pharmaceutical development or manufacturing at all stages of development Demonstrated expertise in Design of Experiments (DoE), multivariate analysis, process capability and variability analysis, statistical modeling of manufacturing processes Working knowledge of formulation principles and solid oral dosage formulation and unit operations (granulation, blending, encapsulation, compression, coating) required Hands‑on experience strongly preferred (supporting late‑stage development and regulatory submissions such as IND/IMPD/CTA/NDA/BLA/MAA) Proficiency with analytical platforms such as JMP, R, Python, or equivalent statistical tools Strong ability to influence cross‑functional teams through technical expertise and data interpretation Act as a portfolio‑level technical authority for quantitative approaches throughout the drug product lifecycle, mentor scientists, strengthen quantitative capabilities, guide experimental design, process characterization, and control strategy development Support regulatory submissions with defensible statistical methodology, integrate datasets across development, analytical, and manufacturing functions, and provide advanced statistical analysis, modeling, and interpretation across CMC development programs Engage in translational analysis of complex development, analytical, and manufacturing data into actionable technical insights, ensuring statistical rigor and regulatory defensibility of CMC data packages and submissions Promote adoption of modern data science and modeling approaches to improve efficiency and process understanding Compensation and Benefits Annual base salary range: $0.00 – $0.00 (based on location, complexity, responsibility, and experience) Annual bonus target: 35% of earned base salary Equity‑based long‑term incentive program eligibility Retirement savings plan with company match Paid vacation, holiday, and personal days Paid caregiver/parental and medical leave Health benefits including medical, prescription drug, dental and vision coverage (subject to applicable plans) EEO & Diversity 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. #J-18808-Ljbffr