Scientist, Clinical Pharmacology jobs in United States
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Neurocrine Biosciences · 7 hours ago

Scientist, Clinical Pharmacology

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological disorders. The Scientist in Clinical Pharmacology will oversee bioanalysis at contract research organizations, ensuring compliance with regulatory requirements and managing bioanalytical method development and validation.

BiotechnologyHealth CarePharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Supporting aspects of bioanalytical outsourcing (method development, validation, and sample analysis) at bioanalytical contract research organizations (CRO) according to project-relevant regulatory requirements and industry standards for both small and large molecule
Oversee sample transfer and tracking from clinical sites or central lab to bioanalytical CROs
Ensure CROs are provided with requisite supplies and information to conduct sample analysis, including provision of reference and internal standards, CoA recertification, and statement of work completion
Review bioanalytical study plans, study protocols, bioanalytical data, and bioanalytical reports to ensure regulatory alignment
Plan and track bioanalytical method development, validation, and sample analysis activities to meet data requirements in accordance with study protocols and team timelines
Attend regular meetings with CROs to facilitate updates. Capture important expectations and agreed to tasks in post-meeting minutes and share minutes with CROs and relevant NBI personnel
Work with Preclinical Operations to establish contracts and work orders for bioanalytical projects
Provide routine status updates to NBI Clinical Pharmacology, Clinical, Accounting, and Biometrics colleagues
Review data transfer protocols, ensure proper data format, investigate data discrepancies and support data consolidation
Other tasks as assigned

Qualification

Bioanalytical method developmentClinical sample analysisRegulatory knowledge (FDA/ICH M10)PharmacokineticsProject managementAnalytical thinkingCommunication skillsTeamworkProblem-solving skillsAttention to detail

Required

BS/BA degree in science related field or similar and 2+ years of pharmaceutical/biotech experience
Experience in managing clinical Contract Research Organizations, preparation of INDs, CTDs, NDAs, and MAAs and working in a cross functional team and matrix environment
Experience developing small/large molecule compounds for CNS indications and silico modeling and simulation tools is beneficial
MS/MA degree in Pharmacokinetics, Pharmaceutical Sciences, or closely related discipline and 1+ years of similar experience noted above
Experience supporting the development, validation, and troubleshooting of bioanalytical methods and clinical sample analysis in one or more of the following disciplines: small molecule, peptides, antibodies, and gene therapy
Knowledgeable on current regulatory guidance/regulations (FDA/ICH M10)
Demonstrates solid level of understanding project/group goals and methods
Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes
Moderate knowledge of scientific principles, methods and techniques in small or large molecule bioanalysis
Detail oriented yet can see broader picture of scientific impact on team
Strong project management skills
Excellent computer skills
Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
Strong problem-solving and analytical thinking skills
Strong written, presentation, and verbal communication skills
Proactive, innovative, with good problem-solving skills
Ability to work as part of a team

Benefits

Annual bonus with a target of 20% of the earned base salary
Eligibility to participate in our equity based long term incentive program
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

Company

Neurocrine Biosciences

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Neurocrine Biosciences engages in the discovery and development of drugs for the treatment of neurological and endocrine-related diseases.

H1B Sponsorship

Neurocrine Biosciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (9)
2023 (8)
2022 (2)
2021 (5)
2020 (6)

Funding

Current Stage
Public Company
Total Funding
$260M
Key Investors
Venrock
2015-02-19Post Ipo Equity· $250M
2009-12-17Post Ipo Equity· $10M
1996-05-31IPO

Leadership Team

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Matt Abernethy
Chief Financial Officer
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Dimitri Grigoriadis
VP, Research
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Company data provided by crunchbase