Principal Scientist, Large Molecule DMPK

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Principal Scientist, Large Molecule DMPK

Apply remote type On-Site locations US CA San Diego time type Full time posted on Posted Yesterday job requisition id R5444

Who We Are :

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

What We Do :

Neurocrine Biosciencesis a leading neuroscience-focused, biopharmaceutical company with a simple purpose : to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis

• and uterine fibroids,
• as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visitneurocrine.com , and follow the company on ,X andFacebook . (
• in collaboration with AbbVie )

About the Role :

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.

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 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

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

#LI-OB1

Neurocrine Biosciences is an EEO / Disability / Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment , and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $128,200.00-$185,900.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties / requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. 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.

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Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma 2024.

We were also named a Great Place to Work Certified company.

Come join our team during this exciting time of growth and opportunities!

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