Sr. Manager Document & Clinical Systems

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, 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 more than 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, Facebook and YouTube. (*in collaboration with AbbVie)

At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.

About the Role:

Responsible for leading the strategy, oversight, quality, compliance, and operational execution of the electronic Trial Master File (eTMF) across one or more clinical development programs. Serves as the TMF subject matter expert (SME) and works cross-functionally with Clinical Operations, CROs, Functional Areas, Quality Assurance, Regulatory Affairs, and Clinical Systems to ensure TMFs are inspection-ready throughout the lifecycle of each study.

Provides leadership for TMF processes, vendor oversight, inspection readiness, metrics, training, and continuous process improvement while ensuring compliance with ICH-GCP, FDA, EMA, MHRA, and other global regulatory requirements.

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

• Leads, mentors, and develops junior team members by providing performance management, coaching, onboarding, training, and career development while ensuring successful delivery of study and departmental objectives

• Provides strategic leadership and oversight for TMF operations across assigned clinical studies, ensuring timely, compliant, and inspection-ready TMFs through effective document management, quality review, remediation, and query resolution

• Serves as the eTMF Subject Matter Expert (SME), providing strategic and technical guidance to study teams, functional areas, CROs, vendors, and end users while promoting TMF best practices and regulatory compliance

• Establishes and monitors departmental priorities, work plans, schedules, resource allocation, and key performance indicators to ensure achievement of business objectives and study milestones

• Builds and maintains strong cross-functional partnerships with Clinical Operations, Regulatory, Biometrics, Pharmacovigilance, Clinical Supply, CROs, vendors, and othe