Translational Medicine Operations Specialist

Neurocrine Biosciences; San Diego (CA); On-site; USD 90,000 - 123,000; Full time

Benefits offered by this job

Retirement plan

Paid vacation

Holidays and personal days

Parental/maternity and medical leave

Healthcare benefits

Job summary

Neurocrine Biosciences is seeking a Clinical Operations professional to drive operational delivery for early-phase studies, coordinating CROs, labs, and assay development. You will track budgets, timelines, and study deliverables while ensuring GxP compliance.

The role emphasizes cross-functional collaboration with Translational Medicine, Regulatory, and Data Management, leveraging Smartsheet and Excel to maintain rigorous documentation and timely data delivery.

Qualifications

• BS/BAMS with 2+ years of relevant industry experience or advanced degrees with experience.
• Operational rigor and attention to detail in fast-paced environments.
• Ability to meet multiple deadlines with high accuracy and efficiency.
• Experience working with CROs and external laboratories in clinical studies.
• Strong written and verbal communication across cross-functional teams.

Responsibilities

• Support clinical Therapeutic Area operations for FIH and early-phase studies.
• Coordinate activities with CROs and external vendors for assays and labs.
• Track contracts, scopes of work, budgets, and timelines with stakeholders.
• Use Smartsheet, Excel and other PM tools to monitor deliverables and risks.
• Integrate operational plans into clinical protocols and study execution plans.
• Monitor vendor performance and escalate risks impacting timelines or quality.
• Collaborate across Translational Medicine, Outsourcing, Clinical Operations, Regulatory, QA, and Data Management.
• Drive planning and execution of specimen collection, testing, and data delivery.
• Maintain GxP-compliant documentation and inspection readiness.

Skills

Operational rigor

Attention to detail

Deadline management

Cross-functional collaboration

Communication skills

Education

BS/BAMS in Biology or Chemistry

MS/MS in Biology or Chemistry

PhD in Biology or Chemistry

Tools

Smartsheet

Excel

Job description

Neurocrine Biosciences is seeking a Clinical Operations professional to drive operational delivery for early-phase studies, coordinating CROs, labs, and assay development. You will track budgets, timelines, and study deliverables while ensuring GxP compliance.

The role emphasizes cross-functional collaboration with Translational Medicine, Regulatory, and Data Management, leveraging Smartsheet and Excel to maintain rigorous documentation and timely data delivery.