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At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.
What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, and Facebook. (*in collaboration with AbbVie)
About the Role:
Contribute to overall clinical trial strategy and manage the operational activities supporting planning, initiation, conduct, and close-out phases of clinical studies. Lead and oversee the end-to-end operational activities of assigned clinical studies (domestic and global). Manage studies through multiple CROs and internal teams. Ensure the integrity of clinical trial data and completeness of Trial Master File (TMF) documentation.
Your Contributions (include, but are not limited to):
1. Develop, lead, and manage NBI trials end-to-end, contributing to overall study strategy and planning.
2. Serve as the primary contact for clinical operations of assigned studies, potentially overseeing other team members.
3. Participate in, and lead when appropriate, discussions on study design, providing expert counsel on protocols and reports.
4. Manage multiple CROs and CSPs for assigned studies.
5. Oversee study team meetings, manage study timelines, and develop recruitment strategies.
6. Manage internally run studies, including monitoring teams and developing study plans and tools.
7. Collaborate with clinical operations to develop and enforce standard processes.
8. Maintain TMF content, ensuring all documents are appropriately filed and inspection-ready.
9. Ensure compliance with FDA, EU, ICH, and internal SOPs and policies.
10. Incorporate risk-based monitoring and work with QA to ensure subject safety and data integrity.
11. Support recruitment, training, and development of clinical operations staff.
12. Perform other duties as assigned.
Requirements:
1. BS/BA with 8+ years of clinical trial management experience, including CRO/vendor management, monitoring, or related fields; or
2. Master’s degree with 6+ years of relevant experience; or
3. Expert knowledge of clinical drug development, ICH, GCPs, FDA regulations, and EU directives.
Additional qualifications include strong knowledge of clinical operations, trial management, industry understanding, resource organization, leadership, communication, and project management skills. Proven ability to analyze data, improve processes, and lead teams effectively.
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Neurocrine Biosciences is an EEO/AA/Disability/Vets employer. We are committed to diversity, equity, and inclusion and encourage qualified candidates to apply regardless of background or experience mismatches.
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