Scientist, Clinical Pharmacology

Neurocrine Biosciences • San Diego, CA

6d

About The Position

Responsible for overseeing aspects of bioanalysis at contract research organizations (CRO) according to project-relevant regulatory requirements and industry standards. Work with Preclinical Operations to establish contracts and work orders for bioanalytical projects. Work with Clinical Pharmacology, 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 important expectations and agreed-to tasks in support of Neurocrine's clinical development programs.

Requirements

• 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.
• 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 project management skills
• 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

Nice To Haves

• 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

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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level