TEMP - Sr. Scientist, Clinical Pharmacology

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. Work with Preclinical Operations to establish contracts and work orders for bioanalytical projects. Coordinate 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.

• 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 critical 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 stakeholders.
• Other tasks as assigned.

• 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 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.

The pay you should reasonably expect to receive is $53.27 – $77.21 per hour. Decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements and relevant experience and skills.

Neurocrine Biosciences is an EEO/Disability/Vets employer.