Scientific Director, Pharmaceutical Development Analytics
Neurocrine Biosciences
August 25, 2026
Remote friendly (San Diego, CA)
United States
Operations
About The Role
The Scientific Director, Pharmaceutical Development Analytics is a portfolio-level quantitative expert responsible for advancing data-driven drug product development across the CMC lifecycle, embedded within MSAT. Applies advanced statistics, experimental design, quantitative modeling, and mechanistic understanding to strengthen formulation/process development, characterization, control strategies, and regulatory submissions.
Your Contributions
- 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; mentor scientists and promote best practices in statistical thinking and experimental design
- Design and apply advanced statistical methods (DoE, multivariate analysis, response surface modeling, process variability analysis)
- Integrate development/analytical/manufacturing data to identify CMAs/CPPs, sensitivities, and design space
- Partner to optimize formulations and manufacturing processes using data-driven and mechanistic approaches; support characterization, scale-up, robustness, risk analysis, troubleshooting, and root-cause investigations
- Guide robust control strategies by linking material attributes, process parameters, and product performance
- Quantitative lead for CMC regulatory submissions (IND, CTA, NDA, BLA, MAA) and lifecycle management; ensure alignment with ICH (Q8, Q9, Q10, Q14)
Requirements
- Bachelor’s in Chemical Engineering + 12+ years pharmaceutical industry experience OR Master’s + 10+ OR PhD + 8+
- Extensive previous managerial experience
- Expertise in DoE, multivariate analysis, process characterization, statistical modeling, and data visualization
- Working knowledge of solid oral dosage formulation/manufacturing (e.g., granulation, blending, compression, coating); hands-on experience preferred
- Late-stage development and global regulatory submission experience
- Proficiency with JMP, R, Python, or comparable statistical software
- Strong collaboration, communication, and technical influencing skills
Benefits (if included)
- Base salary range: $163,400–$223,000; annual bonus target 35% and equity long-term incentive eligibility; retirement match, paid vacation/holidays/personal days, caregiver/parental leave, and health benefits (medical/prescription/dental/vision).
The Scientific Director, Pharmaceutical Development Analytics is a portfolio-level quantitative expert responsible for advancing data-driven drug product development across the CMC lifecycle, embedded within MSAT. Applies advanced statistics, experimental design, quantitative modeling, and mechanistic understanding to strengthen formulation/process development, characterization, control strategies, and regulatory submissions.
Your Contributions
- 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; mentor scientists and promote best practices in statistical thinking and experimental design
- Design and apply advanced statistical methods (DoE, multivariate analysis, response surface modeling, process variability analysis)
- Integrate development/analytical/manufacturing data to identify CMAs/CPPs, sensitivities, and design space
- Partner to optimize formulations and manufacturing processes using data-driven and mechanistic approaches; support characterization, scale-up, robustness, risk analysis, troubleshooting, and root-cause investigations
- Guide robust control strategies by linking material attributes, process parameters, and product performance
- Quantitative lead for CMC regulatory submissions (IND, CTA, NDA, BLA, MAA) and lifecycle management; ensure alignment with ICH (Q8, Q9, Q10, Q14)
Requirements
- Bachelor’s in Chemical Engineering + 12+ years pharmaceutical industry experience OR Master’s + 10+ OR PhD + 8+
- Extensive previous managerial experience
- Expertise in DoE, multivariate analysis, process characterization, statistical modeling, and data visualization
- Working knowledge of solid oral dosage formulation/manufacturing (e.g., granulation, blending, compression, coating); hands-on experience preferred
- Late-stage development and global regulatory submission experience
- Proficiency with JMP, R, Python, or comparable statistical software
- Strong collaboration, communication, and technical influencing skills
Benefits (if included)
- Base salary range: $163,400–$223,000; annual bonus target 35% and equity long-term incentive eligibility; retirement match, paid vacation/holidays/personal days, caregiver/parental leave, and health benefits (medical/prescription/dental/vision).