Sr. Principal Specialist, Clinical Database Programming
Job Title: Sr. Principal Specialist, Clinical Database Programming
Job Location: US CA San Diego, United States of America
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
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: Provides strategic and operational leadership for the clinical database programming function across Neurocrine’s clinical development portfolio. This is a hands-on role, and accountable for defining standards, governance, and long-term strategy to ensure high-quality, compliant, and scalable clinical databases. Serves as a recognized expert, influencing cross-functional decision-making and driving continuous improvement, innovation, and inspection readiness across all therapeutic areas and development phases. _ Your Contributions (include, but are not limited to): Provide strategic leadership and functional ownership of clinical database programming across all clinical programs and therapeutic areas Define, implement, and oversee standards, processes, and best practices for database programming to ensure consistency, quality, and regulatory compliance Mentor, train, and develop team members (as required) Lead and perform clinical database programming activities, including database build, data review and cleaning programs, validation and derivation procedures, database migrations, Targeted SDV configuration, SAS dataset creation, and Global Library maintenance, ensuring the highest standards of quality, compliance, and inspection readiness. Partner within Data Management and Analytics & Data Sciences (ADS) as well as cross-functional leadership to help develop long-arrange plans, resourcing, and operating models aligned with corporate objectives Oversee database timelines, risks, and dependencies; proactively identify and mitigate complex technical/systemic issues that could impact quality, inspection readiness, or submissions Oversee vendor quality and performance, including CROs and consultants, ensuring alignment with internal standards and expectations Lead evaluation, implementation, validation, and adoption of new technologies, platforms, and system enhancements related to data collection, validation, integration, and review Assess the impact of and oversee software updates, including impact to team processes and workflows, and document findings, risks, and recommended actions Ensure inspection readiness and regulatory compliance through proactive oversight of SOPs, work instructions, documentation practices, and quality metrics Act as a liaison across Clinical Data Management (and ADS), Clinical Operations, DSPV, Regulatory, I