Sr. Scientist, Clinical Pharmacology
Neurocrine Biosciences
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Sr. Scientist, Clinical Pharmacology

Neurocrine Biosciences

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Details
Posted:
June 23, 2021
Location:
San Diego, California
Type:
Full Time - Experienced
Preferred Education:
Doctorate

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 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
  • Work with Preclinical Operations to establish contracts and work orders for bioanalytical projects
  • Plan and track bioanalytical method development, validation and sample analysis activities to meet data requirements according to study protocols and team timelines
  • Review bioanalytical validation plans, bioanalytical study protocols and bioanalytical data
  • Hold 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
  • Provide routine status updates to NBI Clinical Pharmacology, Clinical and Biometrics colleagues
  • Document and summarize characteristics for available assays
  • Review data transfer protocols, ensure proper data format, investigate data discrepancies and support data consolidation
  • Oversee sample transfer from nonclinical and 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
  • Contributes to relevant sections of INDs/CTAs/NDAs/MAAs
  • Other tasks as assigned

Requirements:

  • BS/BA degree in science related field or similar and 5+ years of pharmaceutical/biotech Experience in managing clinical Contract Research Organizations, preparation of INDs, CTDs, NDAs, and MAAs and working in a cross functional team and matrix environment. Experience developing small molecule compounds for CNS indications and silico modeling and simulation tools is beneficial OR
  • MS/MA degree in Pharmacokinetics, Pharmaceutical Sciences, or closely related discipline and 3+ years of similar experience noted above OR
  • PhD in Pharmacokinetics, Pharmaceutical Sciences, or closely related discipline and some relevant experience as noted above; may include postdoc experience
  • Hands-on experience with the development, validation and troubleshooting of the bioanalytical methods and clinical sample analysis
  • Knowledgeable on current regulatory guidance / regulations
  • 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

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

NOTES:
Employer will assist with relocation costs.
Internal Number: R2668
About Neurocrine Biosciences
Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, with three pivotal and five mid-stage clinical programs in multiple therapeutic areas. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. (*in collaboration with AbbVie)
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