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 senior technical individual contributor and portfolio-level quantitative expert responsible for advancing data-driven drug product development across the CMC lifecycle, strengthening formulation and process development, process characterization, control strategies, and regulatory submissions.
Responsibilities:
- Serve as 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 (DoE, multivariate analysis, response surface modeling, process variability analysis)
- Integrate development, analytical, and manufacturing data to identify CMAs/CPPs, process sensitivities, and design space
- 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
- Support CMC regulatory submissions (IND, CTA, NDA, BLA, MAA) and lifecycle management; ensure alignment with ICH Q8/Q9/Q10/Q14
- Provide scientifically defensible interpretation of CMC data for regulatory responses
Requirements:
- Bachelor’s in Chemical Engineering + 12+ years; OR Master’s + 10+ years; OR PhD + 8+ years (pharmaceutical industry)
- Expertise in DoE, multivariate analysis, process characterization, statistical modeling, and data visualization
- Solid oral dosage formulation/manufacturing knowledge (granulation, blending, compression, coating); hands-on 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
Compensation/Benefits:
- Annual bonus target 35% of earned base salary; eligibility for equity-based long-term incentive program
- Retirement savings plan (with company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision)
Application instructions:
- Apply even if your experience/qualifications don’t exactly match the job description.
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, strengthening formulation and process development, process characterization, control strategies, and regulatory submissions.
Responsibilities:
- Serve as 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 (DoE, multivariate analysis, response surface modeling, process variability analysis)
- Integrate development, analytical, and manufacturing data to identify CMAs/CPPs, process sensitivities, and design space
- 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
- Support CMC regulatory submissions (IND, CTA, NDA, BLA, MAA) and lifecycle management; ensure alignment with ICH Q8/Q9/Q10/Q14
- Provide scientifically defensible interpretation of CMC data for regulatory responses
Requirements:
- Bachelor’s in Chemical Engineering + 12+ years; OR Master’s + 10+ years; OR PhD + 8+ years (pharmaceutical industry)
- Expertise in DoE, multivariate analysis, process characterization, statistical modeling, and data visualization
- Solid oral dosage formulation/manufacturing knowledge (granulation, blending, compression, coating); hands-on 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
Compensation/Benefits:
- Annual bonus target 35% of earned base salary; eligibility for equity-based long-term incentive program
- Retirement savings plan (with company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision)
Application instructions:
- Apply even if your experience/qualifications don’t exactly match the job description.