Clinical Compliance Manager

Who We Are:

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:

Independently leads and collaborates with Clinical Operations (ClinOps) to drive strategic initiatives related to clinical process compliance, continuous improvement, and inspection readiness. Plays a pivotal role in shaping and implementing process enhancements, including study-specific training programs and management of NBI consent document templates. Oversees the facilitation of training and the creation and revision of controlled documents to ensure operational excellence. Serves as a key ClinOps liaison, adept at identifying procedural gaps and championing innovative solutions to enhance efficiency and effectiveness across clinical processes.

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Your Contributions (include, but are not limited to):

• Guides study teams on audit/inspection activities, offering insights on findings, and escalating issues to Clinical Compliance (CC) Director when necessary

• Serves as the ClinOps point person, providing key advice on clinical processes and Good Clinical Practices (GCP)

• Develops and reviews new or updated ClinOps controlled documents, coordinate input from Subject Matter Experts (SMEs), assess impact, propose implementation plans, and manage timelines

• Leads process integration and collaboration with vendors (e.g., CROs)

• Oversees the management and updating of NBI consent document templates and related documents

• Collaborates with NBI Drug Safety and Pharmacovigilance (DSPV) to ensure compound risk language is accurately included in consent documents

•  Manages and oversees SST activities, such as maintenance SST matrix templates, processing of document submissions for SST assignments, and compliance with SST processes

• Manages SST system solution implementation, updates and user access

• Manages ClinOps training activities, including developing training materials and conducting live training sessions under guidance from CC Director

• Oversees the distribution lists (DL) management process (e.g., ensure DLs for internal distribution of safety reports