Director, Standards & Integrations

Neurocrine Continental; San Diego (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Neurocrine Biosciences is seeking a Director to lead the Standards and Integration strategy for automation-centric AI-enabled biometrics workflows across the clinical development portfolio. You will ensure regulatory-compliant data collection, analysis, and reporting while partnering with Data Management, Statistical Programming, Biostatistics, Data Science, IT and Quality.

Reporting to the Executive Director, you will manage a team, oversee strategic outsourcing, and maintain external

Qualifications

• Leads the Standards and Integration strategy across biometrics workflows.
• Drives automation and AI controls to ensure regulatory-compliant data handling.
• Manages a team including subordinate leaders and external vendors.

Responsibilities

• Translate strategy into priorities and execution plans; coach and develop the team.
• Improve foundational standards for automation, mappings, and templates.
• Oversee design and quality of submission outputs and inspection readiness.
• Lead low/no-code and programmatic automations across Data Management, Statistics, Biostatistics.

Skills

Leadership

Strategic thinking

Cross-functional collaboration

Decision making

Tools

SAS

R

Python

SQL

Job description

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

The role will lead the execution of the Standards and Integration strategy through automation-centric, AI-enabled biometrics workflows that scale and accelerate delivery across the clinical development portfolio, from protocol finalization through final Tables, Figures, and Listings (TFLs). Grounded in reusable metadata, lifecycle governance, content reuse and responsible-AI controls, this role ensures regulatory-compliant data collection, analysis, and reporting and sustained inspection readiness.

The Director partners closely with Data Management, Statistical Programming, Biostatistics, Data Science, IT and Quality to operationalize data and analysis requirements into integrated workflows and to design tools that enable seamless handoffs across functions. Reporting to the Executive Director, the role leads a team of standards and automation professionals, including subordinate leaders, manages strategic outsourcing and external vendors, and maintains external connections to stay current with, and helps shape, industry standards.

Your Contributions (include, but are not limited to)

• Translate the Standards and Integration strategy into operational priorities, execution plans and measurable outcomes aligned with company goals and ADS leadership; lead, coach and develop the team, including subordinate leaders
• Lead continuous improvement of foundational standards that enable automation and consistent execution across studies (e.g., standards rulesets, mappings, reusable templates, workflow checklists, and controlled specifications)
• Drive standards implementation aligned to CDISC expectations, with strong linkage between CDASH-compliant data collection, downstream CDISC-compliant SDTM/ADaM data, and Neurocrine standard analysis and reporting
• Submission readiness: Oversee design and quality of submission-critical outputs, including the Define-XML package, ensuring traceability, consistency and an inspection-readiness mindset
• Lead the design, development, validation and deployment of low/no-code and programmatic (SAS, R, Python, SQL) automations, including reusable macros and functions, ETL workflows, and data quality checks and alerts, which improve: Standards adherence and consistency
• Handoff quality between Data Management, Statistical Programming and Biostatistics
• Repeatability of analysis and reporting workflows
• Inspection readiness through controlled outputs and documentation
• Enable governed AI use within Biometrics (use cases, access restrictions, peer review, and automated checks); define inspection-ready evidence for automated and AI-assisted outputs; and provide training and technical support to drive adoption
• Contribute to ADS technology strategy; lead evaluation, implementation and lifecycle oversight of assigned biometrics technologies, including software identification, acquisition, validation and maintenance, in partnership with ADS leadership, IT and Quality
• Lead implementation, adoption and sustained use of standards and automation solutions across Data Management, Statistical Programming and Biostatistics; monitor performance and resolve cross-functional delivery issues
• Collaborate with Data Science, IT and other departments to generate insights from integrated clinical and non-clinical data sources that inform strategic decision-making
• Develop and execute outsourcing plans within approved priorities and resource allocations; manage ex