Clinical Trials Project Lead

Neurocrine Biosciences, Inc.; San Diego (CA); On-site; USD 111,000 - 151,000; Full time

Job summary

Neurocrine Biosciences, Inc. is seeking a Senior Clinical Trials Operations Lead to support planning, initiation, conduct, and close-out of assigned clinical studies (domestic and global).

The role collaborates with CTMs and CROs to ensure studies adhere to FDA regulations, ICH guidelines, and internal SOPs. You will develop study timelines, contribute to recruitment efforts, and help monitor and guide study activities across programs.

Qualifications

• BS/BA in Scientific field or equivalent with 4+ years of clinical trials/operations experience preferred.
• Master's in Scientific field or equivalent with 2+ years experience.
• Knowledge of FDA regulations, ICH, GCPs, EU Directives.
• Experience coordinating with CROs and internal teams.
• Strong analytical and problem-solving skills.

Responsibilities

• Partner with CTMs to ensure trials comply with FDA regulations, EU Directives, ICH guidelines and SOPs.
• Lead smaller studies and act as team member for assigned studies.
• Develop reports and provide insights for study design discussions.
• Manage project plans, tracking metrics, issues lists and CRO/CSP oversight.
• Lead or participate in study team meetings; create timelines aligned with corporate goals.

Skills

Clinical trial management

FDA regulations

ICH guidelines

CRO oversight

Project coordination

Education

BS/BA in scientific field

Master's degree in scientific field

Job description

Neurocrine Biosciences, Inc. is seeking a Senior Clinical Trials Operations Lead to support planning, initiation, conduct, and close-out of assigned clinical studies (domestic and global).

The role collaborates with CTMs and CROs to ensure studies adhere to FDA regulations, ICH guidelines, and internal SOPs. You will develop study timelines, contribute to recruitment efforts, and help monitor and guide study activities across programs.