Scientific Director, Pharmaceutical Development Analytics
Neurocrine Biosciences
July 02, 2026
Remote friendly (San Diego, CA)
United States
Operations
About The Role
The Scientific Director, CMC Quantitative Sciences is a senior individual contributor responsible for designing and advancing data-driven development and lifecycle management initiatives for drug products using advanced statistical analysis, experimental design, and quantitative modeling.
Your Contributions
- Own drug product design and development strategy; generate, maintain, and leverage process understanding and development data; inform control strategy for regulatory submission.
- Provide advanced statistical analysis and modeling across CMC programs; translate complex development/manufacturing data into actionable insights; ensure statistical rigor and regulatory defensibility; serve as a technical authority for statistical interpretation across lifecycle stages.
- Apply multivariate tools to identify CMAs/CPPs and define design space boundaries; guide root-cause investigations involving process variability; integrate datasets across development, analytical, and manufacturing; translate experimental data into formulation and process understanding.
- Support formulation/process development (DoE, mixture designs, response surface methods; unit operations such as granulation, blending, compression, coating); contribute to robust manufacturing processes and robustness/sensitivity analyses.
- Support regulatory submissions (NDA, BLA, MAA) as primary statistical authority; ensure alignment with ICH (Q8, Q9, Q10, Q14); provide statistical interpretation for validation/control strategy.
- Strengthen quantitative capabilities; establish best practices; mentor scientists.
Requirements
- PhD, PharmD, or MS in Statistics, Chemical Engineering, Pharmaceutical Sciences, or related field.
- 12–15+ years applying statistical analysis to pharmaceutical development/manufacturing.
- Expertise in DoE, multivariate analysis, process capability/variability, statistical modeling.
- Working knowledge of solid oral dosage formulation and unit operations (hands-on preferred).
- Experience with late-stage development and IND/IMPD/CTA/NDA/BLA/MAA.
- Proficiency with JMP, R, Python, or equivalent.
- Strong ability to influence cross-functional teams.
Benefits (as described)
- Retirement savings plan (company match); paid vacation/holidays/personal days; caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision).
- Annual bonus (target 35% of earned base) and eligibility for equity long-term incentive program.
The Scientific Director, CMC Quantitative Sciences is a senior individual contributor responsible for designing and advancing data-driven development and lifecycle management initiatives for drug products using advanced statistical analysis, experimental design, and quantitative modeling.
Your Contributions
- Own drug product design and development strategy; generate, maintain, and leverage process understanding and development data; inform control strategy for regulatory submission.
- Provide advanced statistical analysis and modeling across CMC programs; translate complex development/manufacturing data into actionable insights; ensure statistical rigor and regulatory defensibility; serve as a technical authority for statistical interpretation across lifecycle stages.
- Apply multivariate tools to identify CMAs/CPPs and define design space boundaries; guide root-cause investigations involving process variability; integrate datasets across development, analytical, and manufacturing; translate experimental data into formulation and process understanding.
- Support formulation/process development (DoE, mixture designs, response surface methods; unit operations such as granulation, blending, compression, coating); contribute to robust manufacturing processes and robustness/sensitivity analyses.
- Support regulatory submissions (NDA, BLA, MAA) as primary statistical authority; ensure alignment with ICH (Q8, Q9, Q10, Q14); provide statistical interpretation for validation/control strategy.
- Strengthen quantitative capabilities; establish best practices; mentor scientists.
Requirements
- PhD, PharmD, or MS in Statistics, Chemical Engineering, Pharmaceutical Sciences, or related field.
- 12–15+ years applying statistical analysis to pharmaceutical development/manufacturing.
- Expertise in DoE, multivariate analysis, process capability/variability, statistical modeling.
- Working knowledge of solid oral dosage formulation and unit operations (hands-on preferred).
- Experience with late-stage development and IND/IMPD/CTA/NDA/BLA/MAA.
- Proficiency with JMP, R, Python, or equivalent.
- Strong ability to influence cross-functional teams.
Benefits (as described)
- Retirement savings plan (company match); paid vacation/holidays/personal days; caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision).
- Annual bonus (target 35% of earned base) and eligibility for equity long-term incentive program.