Principal Scientist, Molecule DMPK

Overview

Who We Are:

At Neurocrine Biosciences, we prize a strong, inclusive, and positive culture based on our shared purpose and values, focused on relieving suffering for people with great needs.

Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We discover and develop life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The companys portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington s disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, and a robust pipeline in mid- to late-phase clinical development across core therapeutic areas.

For three decades, we have applied our neuroscience insight to treat complex conditions. We pursue medicines to ease the burden of debilitating diseases because you deserve brave science. For more information, visit  and follow the company on Linked In, X, and Facebook. (
* in collaboration with Abb Vie)

About the Role: Neurocrine’s Drug Metabolism and Pharmacokinetics (DMPK) team is seeking an experienced pharmaceutical scientist to lead the application of absorption, distribution, metabolism, excretion (ADME) science to advance our large molecule portfolio. Working on cross-functional teams, the group uses in silico, in vitro, and in vivo approaches to mechanistically study pharmacokinetics, absorption, and disposition of small molecules, biologics, peptides, gene therapies, and other complex modalities.

You will serve as a technical leader within DMPK and participate in all stages of ADME assessment, from initial screening through IND and NDA regulatory submissions. The role will require engagement in experimental design and data interpretation to deliver the discovery and development portfolio of investigational targets and novel therapeutics. The candidate will represent DMPK on Research and Development teams and interface with internal and external colleagues to ensure timely and accurate dissemination of ADME information.

Your Contributions (include, but are not limited to):

• 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
• Provide mentorship to and frequently supervise the day-to-day work of less experienced team members

Requirements:

• 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. Extensive training in drug metabolism and disposition or clinical pharmacology is required OR
• MS/MA in biology, chemistry, or related science field and 10+ years of similar experience named above OR
• PhD or equivalent with 4+ years of relevant experience; may include postdoc experience
• Demonstrated results/experience in working with interdisciplinary teams
• Working knowledge of principles of ADME and pharmacokinetics
• Solid understanding of organic/medicinal chemistry
• Strong communication skills (written and verbal)
• Ability to lead, guide and influence teams in decision making
• Proficient in analyzing and visualizing multi-dimensional scientific data
• Excellent communication, problem-solving, analytical thinking skills
• Excellent project management skills
• Ability to mentor and direct day-to-day work of less experienced team members
• Expertise acting as a large molecule DMPK representative on discovery teams
• Ability to work as part of and lead multiple teams
• Excellent written and verbal communication skills
• Evaluate and apply innovative PK and PK/PD approaches to predict human PK, using modeling to generate hypotheses, design studies, inform clinical plans, and support registration
• Experience with mathematical modeling workflows using software such as R, Matlab, Python, Sim Cyp, Win Non Lin , Simulations Plus, Monolix, etc.
• Proficient in scripting/programming in Python, C/C++, or R
• Build a strong external network and stay up to date with emerging literature in the area
• See the broader impact on multiple…