Principal Scientist, Large Molecule DMPK

Role Summary

Principal Scientist, Large Molecule DMPK who leads ADME science for Neurocrine’s large molecule portfolio. Acts as a technical leader within DMPK, contributing to all stages of ADME assessment from screening through regulatory submissions, and collaborates across research and development teams to disseminate ADME information.

Responsibilities

• Acts as a DMPK representative on project teams providing scientific and strategic input
• Design, execute, and manage the conduct, interpretation, and reporting of in vitro drug metabolism data, in vivo PK studies, and PK-PD studies
• Prepare data summaries and present results to peers, colleagues, project teams and leadership
• Oversee outsourcing partners of DMPK studies, ensuring partners adhere to contractual standards, within budget
• Provide expert level contribution in the preparation and review of regulatory submissions
• Integrate in vitro ADME, in vivo PK, and PK/PD endpoints with discovery biology data to define structure activity- and structure-property-relationships to guide optimization strategies
• Develop data visualization strategies to ensure consistent data interpretation across project teams to drive portfolio decisions
• Aid in ADME knowledge management
• Apply innovative mechanistic modeling approaches to translate and predict human PK, inform clinical plans, and support compound registration
• Mentor and supervise day-to-day work of less experienced team members

Qualifications

• BS/BA in biology, chemistry, or related science field and 12+ years of hands-on experience as DMPK project team representative with emphasis on large molecule modalities
• MS/MA in biology, chemistry, or related field and 10+ years of similar experience
• PhD or equivalent and 4+ years of relevant experience
• Demonstrated results in interdisciplinary teams
• Working knowledge of ADME and pharmacokinetics; solid understanding of organic/medicinal chemistry
• Strong communication skills (written and verbal) and ability to lead teams
• Proficiency in analyzing and visualizing multi-dimensional data; excellent problem-solving and project management skills
• Experience with PK/PD modeling and software (e.g., R, Matlab, Python, SimCyp, WinNonLin, SimulationsPlus, Monolix)
• Programming/scripting in Python, C/C++, or R
• Ability to mentor, lead multiple teams, and build external networks
• Ability to meet multiple deadlines with high accuracy and efficiency

Education

• PhD or equivalent preferred; otherwise advanced degree with extensive relevant experience