TEMP - Sr. Scientist, Clinical Pharmacology
On-site · San Diego, California, United States
Job Summary
Senior Scientist, Clinical Pharmacology responsible for bioanalytical method development, validation and sample analysis at CROs according to regulatory standards. Oversees CRO contracts/work orders, plans and tracks bioanalytical activities to support Neurocrine's clinical development programs, ensures CROs deliver required data, and collaborates with Clinical Pharmacology, Clinical Operations, R&D Operations, and QA. Requires advanced degrees in pharmacokinetics, pharmaceutical sciences, or clinical pharmacology and hands-on experience with bioanalytical method development/validation for small and large molecules; knowledge of regulatory guidance (ICH M10); strong problem-solving, data interpretation, and communication skills; ability to manage projects and work within a team. Location: San Diego, CA (on-site). The role emphasizes contract research organization coordination, data transfer, and ensuring data quality to meet study protocols and timelines.
Required Qualifications
- BS in Pharmacokinetics, Pharmaceutical Sciences, clinical pharmacology, or a related scientific discipline and 4+ years of experience in clinical-stage pharmaceutical development
- MS in Pharmacokinetics, Pharmaceutical Sciences, clinical pharmacology, or a related scientific discipline and 3+ years of similar experience
- PhD in Pharmacokinetics, Pharmaceutical Sciences, clinical pharmacology, or a related scientific discipline and some relevant experience
- Hands-on experience with the development, validation and troubleshooting of bioanalytical methods and clinical sample analysis for small and large molecules
- Knowledgeable on current regulatory guidance / regulations (ICH M10)
- Demonstrates solid level of understanding of project/group goals and methods
- Excellent problem-solving and analytical thinking skills
- Excellent written, presentation, and verbal communication skills
- Strong project management skill
- Ability to work as part of a team; may train lower levels
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