Senior Principal Scientist, DMPK Translational PKPD Modeling

Role Summary

As a member of the DMPK group, design and implement mechanistic PK/PD models in support of Neurocrine’s pre-clinical biologics portfolio, including peptide, antibody, and antibody-drug conjugate. Represent the PK/PD modeling discipline on multi-disciplinary drug discovery project teams and integrate PK/PD and target engagement considerations into team strategy and decision-making. Collaborate with stakeholders to support the translational research strategy and enhance capabilities of the DMPK group by implementing novel approaches and technologies.

Responsibilities

• Independently develop PK/PD models that enhance decision-making for biologics target and candidate selections and inform translational research strategies for biologics
• Use modeling and simulation to predict human efficacious dose/dose regimen and influence selection of Development Candidate
• Design pharmacokinetic studies, analyze and interpret data, and clearly communicate results to teams and management
• Leverage literature data or propose fit for purpose experiments to validate models or test model-generated hypotheses
• Effectively collaborate with scientists within and outside the functional area (biologists, protein engineering scientists, clinical pharmacologists)
• Contribute to the overall translational research strategy by integrating PK/PD and target engagement considerations into team strategy and decision-making
• Prepare clear technical reports and oral presentations
• Develop broad knowledge in the field of expertise and enhances internal capabilities of the group

Qualifications

• PhD in Biochemistry, Pharmacokinetics, Pharmaceutical Sciences, Biochemical Engineering or closely related discipline with a specific focus on PK and PK/PD modeling and 7+ years of experience in the industrial discovery and development of small and large molecular therapeutics; or MS with 13+ years of industry experience
• Theoretical and practical knowledge of pharmacokinetics and PK/PD modeling
• Experience using one or more commercially available modeling and simulation platforms (NONMEM, MATLAB, SimBiology, Simcyp etc.)
• Experience in mechanism-based PK/PD modeling of therapeutic proteins is highly desired
• Proficiency with scriptable modeling and simulation language (e.g., R, MATLAB, Julia)
• Proficiency with PBPK modeling applied to biologics research and development
• Experience with computational tools used for validation and verification of mechanism-based models (e.g., parameter estimation, sensitivity analysis, virtual population/patient simulations)
• Evaluate and apply innovative PK and PK/PD approaches to predict human PK, using modeling as a tool to help generate hypotheses, design studies, inform clinical plans, and support registration
• Working knowledge in immunology is highly desired
• Ability to build effective working relationships and influence others both inside and outside the department