Clinical Operations Lead

Job Description

Sr. Clinical Trials Manager | Neurocrine Biosciences

The Tone:
This is a full-time role at Neurocrine Biosciences, located in San Diego, CA. Neurocrine Biosciences is dedicated to discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. This role is crucial for managing the operational activities of clinical studies, ensuring compliance and data integrity, and ultimately bringing new treatments to patients who need them. The Sr. Clinical Trials Manager will play a vital part in advancing brave science to ease the burden of debilitating diseases.

The TL;DR
• Role: Full Time
• Type: Full-time
• Location: In-person, San Diego, CA
• Pay: $156900–$214000 yearly
• Team: Clinical Operations, leading lower-level and indirect teams
• Mission: Manage the end-to-end operational activities for assigned clinical studies to ensure the successful development and commercialization of new treatments.

What You’ll Actually Do
• Develop Strategy: Develop and lead Neurocrine’s clinical trials from end-to-end, contributing to the overall study strategy and planning.
• Oversee Operations: Serve as the primary point of contact for clinical operations aspects of assigned clinical studies, potentially overseeing other clinical trials.
• Manage Vendors: Oversee multiple Contract Research Organizations (CROs) and other contract service providers for assigned studies, ensuring effective execution.
• Drive Enrollment: Develop and manage study timelines, identify barriers to enrollment, and create recruitment solutions in line with corporate goals.
• Conduct Internally: Manage internally run studies, including supervising trial monitoring teams and developing various study plans, tools, and performing monitoring visits as needed.
• Ensure Compliance: Guarantee clinical studies adhere to Food and Drug Administration (FDA) regulations, EU Directives, International Conference on Harmonization (ICH) guidelines, and Neurocrine Standard Operating Procedures (SOPs).
• Maintain Documentation: Manage the Trial Master File (TMF) content, ensuring all study documents are appropriately filed and inspection-ready throughout the study’s conduct and at completion.

The Must-Haves
• Background: BS/BA degree in a relevant field, or a Master’s degree. This is a senior-level role requiring in-depth expertise within clinical operations.
• Experience: 8+ years of clinical trial management experience, including CRO/vendor management (domestic and international), budget scope monitoring, or clinical site monitoring. Candidates with a Master’s degree require 6+ years of similar experience.
• Skills: Expert knowledge of the clinical drug development process, including ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive. Strong project management and leadership skills, with the ability to manage multiple deadlines across various projects efficiently. Excellent communication, presentation, problem-solving, and analytical thinking skills are essential for internal and external interactions.