Senior Director, Pharmaceutical Development Analytics

neurocrine; San Diego (CA); On-site; USD 260,000 - 340,000; Full time

Job summary

Neurocrine Biosciences seeks a Senior Scientific Director in Pharmaceutical Development Analytics to lead portfolio-level statistical and quantitative sciences for drug product development from post-Concept through commercialization.

You will design advanced DoE, multivariate analyses and modeling, integrate multi-source data, and guide robust control strategies while ensuring regulatory alignment with ICH guidelines. Strong leadership and collaboration are essential.

Qualifications

• Bachelor's degree in Chemical Engineering and 12+ years of pharmaceutical industry experience OR
• Master's degree in Chemical Engineering and 10+ years of similar experience noted above OR
• PhD in in Chemical Engineering and 8 + years of similar experience noted above
• Extensive previous managerial experiences also required
• Demonstrated expertise in DoE, multivariate analysis, process characterization, statistical modeling, and data visualization
• Working knowledge of solid oral dosage formulation and manufacturing processes (e.g., granulation, blending, compression, coating); hands‑on development experience preferred
• Experience supporting late-stage development and global regulatory submissions
• Proficiency with JMP, R, Python, or comparable statistical software
• Excellent collaboration, communication, and technical influencing skills

Responsibilities

• 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
• 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
• 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
• 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

Skills

Design of Experiments

Multivariate analysis

Process characterization

Statistical modeling

Data visualization

JMP

R

Python

Education

Bachelor's in Chemical Engineering

Master's in Chemical Engineering

PhD in Chemical Engineering

Tools

JMP

R

Python

Job description

Neurocrine Biosciences seeks a Senior Scientific Director in Pharmaceutical Development Analytics to lead portfolio-level statistical and quantitative sciences for drug product development from post-Concept through commercialization.

You will design advanced DoE, multivariate analyses and modeling, integrate multi-source data, and guide robust control strategies while ensuring regulatory alignment with ICH guidelines. Strong leadership and collaboration are essential.