Neurocrine Biosciences
Principal Scientist, Large Molecule DMPK
Neurocrine Biosciences, San Diego, California, United States, 92189
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.
What We Do 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 neurocrine.com and follow the company on LinkedIn, X, and Facebook. (*in collaboration with AbbVie)
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, SimCyp, WinNonLin, SimulationsPlus, 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 programs, teams, and/or departments
Ability to meet multiple deadlines across projects with high 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 various 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 exactly with our outlined 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 include a retirement savings plan with company match, paid vacation, holidays and personal days, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with applicable plans.
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What We Do 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 neurocrine.com and follow the company on LinkedIn, X, and Facebook. (*in collaboration with AbbVie)
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, SimCyp, WinNonLin, SimulationsPlus, 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 programs, teams, and/or departments
Ability to meet multiple deadlines across projects with high 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 various 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 exactly with our outlined 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 include a retirement savings plan with company match, paid vacation, holidays and personal days, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with applicable plans.
#J-18808-Ljbffr