TEMP - Senior Scientist, Clinical Pharmacology - Bioanalytical Outsourcing

Neurocrine Biosciences

About The Position

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.

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 (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

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