Senior Principal Scientist, DMPK Translational PKPD Modeling

Neurocrine Biosciences • San Diego, CA

8d

About The Position

As a member of the DMPK group, design and implement mechanistic PK/PD models in support of Neurocrine’s highly innovative 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 in Discovery Research and Clinical Pharmacology and other relevant functions to support the overall translational research strategy for projects as well as enhance capabilities of the DMPK group by implementing novel approaches and technologies.

Requirements

• 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.)
• 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
• Ability to build effective working relationships and influence others both inside and outside the department

Nice To Haves

• Experience in mechanism-based PK/PD modeling of therapeutic proteins is highly desired
• Working knowledge in immunology is highly desired

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

Benefits

• Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 1,001-5,000 employees