TEMP - Senior Scientist, Clinical Pharmacology - Bioanalytical Outsourcing

TEMP - Senior Scientist, Clinical Pharmacology - Bioanalytical Outsourcing page is loaded## TEMP - Senior Scientist, Clinical Pharmacology - Bioanalytical Outsourcing remote type:
On-Site locations:
US CA San Diegotime type:
Full time posted on:
Posted Todayjob requisition :
R6419##

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 Biosciences is 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, visit , and follow the company on ,  and . (
* in collaboration with Abb Vie*)##

About the Role:

Responsible for all aspects of bioanalytical method development, validation and sample analysis at contract research organizations (CRO) according to project-relevant regulatory requirements and industry standards. Working with Preclinical Operations establish contracts and work orders for bioanalytical projects. Work with Clinical Pharmacology and Clinical Operations to plan and track bioanalytical method development, validation and sample analysis to support study initiation, execution and reporting.

Ensure CROs capture and deliver on important expectations and agreed-to tasks in support of Neurocrine's clinical development programs. ## Your Contributions (include, but are not limited to):
* 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## Requirements:
* 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 (ICHM
10)
* 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…