Principal Scientist, Large Molecule DMPK

Neurocrine Biosciences • San Diego, CA

3d

About The Position

Neurocrine’s Drug Metabolism and Pharmacokinetics (DMPK) team is searching for 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, our group applies in silico, in vitro, and in vivo approaches to mechanistically study the pharmacokinetics, absorption, and disposition of small molecules, biologics, peptides, gene therapies, and other complex modalities. You will serve as a technical leader within the DMPK department and participate in all stages of ADME assessment, from initial compound screening through IND and NDA regulatory submissions. This 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 regularly interface with internal and external colleagues to ensure timely and accurate dissemination of ADME information.

Requirements

• BS/BA in biology, chemistry, or related science field and 12+ years of hands-on experience as DMPK project team representative with an emphasis on large molecule modalities. Extensive training in the field of 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 noted above OR PhD or equivalent and 4+ years of relevant experience; may include postdoc experience
• Demonstrated results/experience in working with interdisciplinary teams
• Working knowledge of the 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 the 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 help generate hypotheses, design studies, inform clinical plans, and support registration
• Experience with mathematical modeling workflows using relevant software such as R, Matlab, Python, SimCyp, WinNonLin, SimulationsPlus, Monolix, etc.
• Proficient in scripting/programming in one or more of the following languages: Python, C/C++, R
• Build a strong external network (e.g. academia, consortia) and keep up to date with emerging literature and science in the area.
• Sees broader picture, impact on multiple programs, teams and/or departments
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management skills

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 presents results to peers, colleagues, project teams and leadership
• Oversee outsourcing partners of DMPK studies, ensuring partners adhere to contractual standards, within budget
• Provides 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
• Effectively partner to apply innovative mechanistic modeling approaches to translate and predict human PK, inform clinical plans, and support compound registration
• Will provide mentorship to and frequently supervise the day-to-day work of less experienced team members

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• 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: Mid Level
• Number of Employees: 1,001-5,000 employees