Neurocrine Biosciences · 2 hours ago
TEMP - Senior Scientist, Clinical Pharmacology - Bioanalytical Outsourcing
San Diego, CA
Full-time
Onsite
Mid, Senior Level
3+ years expNeurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological disorders. The Senior Scientist in Clinical Pharmacology will oversee bioanalytical method development, validation, and sample analysis at contract research organizations to support clinical development programs.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Oversee all aspects of bioanalytical method development, validation and sample analysis at contract research organizations (CRO) according to project-relevant regulatory requirements and industry standards for small and large molecule development
Work with R&D Operations and legal departments to establish contracts and work orders for bioanalytical projects
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
Plan and track criticial reagent preparation, bioanalytical method development, validation and sample analysis activities to meet data requirements according to study protocols and timelines
Review bioanalytical validation plans, protocols and bioanalytical data to ensure alignment with current regulatory requirements
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 hold them accountable
Provide routine status updates to NBI Clinical, Clinical Pharmacology, QA, Accounting and Data Sciences colleagues
Review data transfer protocols, ensure proper data format, investigate data discrepancies and support data consolidation
Presents data and recommendations to internal and external stake holders
Other tasks as assigned
Qualification
Required
BS in Pharmacokinetics, Pharmaceutical Sciences, clinical pharmacology, or a related scientific discipline and 4+ years of experience in clinical-stage pharmaceutical development OR
MS in Pharmacokinetics, Pharmaceutical Sciences, clinical pharmacology, or a related scientific discipline and 3+ years of similar experience noted above OR
PhD in Pharmacokinetics, Pharmaceutical Sciences, clinical pharmacology, or a related scientific discipline and some relevant experience as noted above
Hands-on experience with the development, validation and troubleshooting of the bioanalytical methods and clinical sample analysis for small and large molecules
Knowledgeable on current relevant regulatory guidance / regulations (ICHM10)
Demonstrates solid level of understanding project / group goals and methods
Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes
Able to explain the process behind the data and implications of the results
Strong knowledge of one or more scientific disciplines, becoming expert in one discipline
Strong knowledge of scientific principles, methods and techniques
Strong knowledge and demonstrated ability working with a variety of laboratory equipment/tools
Detail oriented yet can see broader picture of scientific impact on team
Excellent computer skills
Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
Strong project management skill
Excellent 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; may train lower levels
Company
Neurocrine Biosciences
Neurocrine Biosciences engages in the discovery and development of drugs for the treatment of neurological and endocrine-related diseases.
1001-5000 employees
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 CompanyTotal Funding
$260MKey Investors
Venrock
2015-02-19Post Ipo Equity· $250M
2009-12-17Post Ipo Equity· $10M
1996-05-31IPO
Leadership Team
Matt Abernethy
Chief Financial Officer
D
Dimitri Grigoriadis
VP, Research
Recent News
BioWorld Financial Watch
2026-01-16
Company data provided by crunchbase