Director, Standards & Integrations

Neurocrine Biosciences • San Diego, CA

1d • $155,500 - $296,000 • Remote

About The Position

The Director, Standards & Integrations leads execution of the Standards and Integration strategy through automation-centric, AI-enabled biometrics workflows that scale and accelerate clinical development delivery from protocol finalization through final Tables, Figures, and Listings (TFLs). The role uses reusable metadata, lifecycle governance, content reuse, and responsible-AI controls to support regulatory-compliant data collection, analysis, and reporting, while maintaining inspection readiness.

The Director partners with Data Management, Statistical Programming, Biostatistics, Data Science, IT, and Quality to operationalize data and analysis requirements into integrated workflows and design tools that enable seamless functional handoffs. 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 help shape industry standards.

Requirements

• 15 or more years of experience; or a bachelor's degree and 12 or more years of relevant biotech, pharmaceutical, or CRO clinical development experience in computer science, mathematics, statistics, or a related field, including experience leading in-house and/or contract teams; or a Ph.D. and 8 or more years of relevant experience.
• Deep knowledge of CDASH and CDISC standards, including SDTM, ADaM, and Define-XML, and increasingly complex regulatory requirements for regulatory-quality data and submissions.
• Advanced SAS or R proficiency, including development and validation of statistical programs and integrated programming libraries.
• Experience with Medidata Rave EDC build and content reuse, including CRF standards, edit checks, and libraries, and downstream readiness.
• Deep knowledge of GxP expectations, data integrity, and audit trails, and experience partnering with IT and Quality on validation.
• Proven success with end-to-end vendor management and developing and managing strategic outsourcing plans.
• Ability to work across Data Management, Biostatistics, Statistical Programming, Data Science, IT, and Clinical Operations, and act as a trusted advisor on standards and automation.
• Experience identifying and evaluating systems and tools for company use.
• Experience leveraging standards to create processes that enable automation and AI-driven solutions to improve Analytics and Data Sciences deliverables.
• Excellent leadership, coaching, communication, and people skills, including the ability to lead, mentor, and develop a team and engage peers and senior leadership.
• Strong analytical judgment and the ability to complete complex, ambiguous initiatives with cross-functional impact; initiative-taking and meticulous.

Nice To Haves

• Python and SQL proficiency.
• Ability to work remotely from California.

Responsibilities

• 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.
• Continuously improve foundational standards that enable automation and consistent execution across studies, including standards rulesets, mappings, reusable templates, workflow checklists, and controlled specifications.
• Drive standards implementation aligned with CDISC expectations, linking CDASH-compliant data collection with downstream CDISC-compliant SDTM/ADaM data and Neurocrine standard analysis and reporting.
• Oversee the design and quality of submission-critical outputs, including the Define-XML package, ensuring traceability, consistency, and inspection readiness.
• Lead the design, development, validation, and deployment of low/no-code and programmatic automations, including reusable macros and functions, ETL workflows, and data-quality checks and alerts.
• Use automation to improve standards adherence, cross-functional handoff quality, repeatability of analysis and reporting workflows, and inspection readiness through controlled outputs and documentation.
• Enable governed AI use within Biometrics by defining use cases and access restrictions, establishing peer review and automated checks, defining inspection-ready evidence for automated and AI-assisted outputs, and providing training and technical support.
• Contribute to ADS technology strategy and 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 to inform strategic decision-making.
• Develop and execute outsourcing plans within approved priorities and resource allocations; manage external vendors from selection through oversight of quality and timeliness.
• Contribute to long-term workforce planning and manage the development and revision of standard operating procedures.
• Identify and implement new tools, technologies, and methodologies; foster continuous improvement; and contribute to industry standards bodies and forums.

Benefits

• Retirement savings plan with company match.
• Paid vacation, holiday, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage, subject to applicable plan terms and conditions.
• Annual bonus with a target of 35% of earned base salary.
• Eligibility to participate in an equity-based long-term incentive program.

What This Job Offers

• Job Type: Full-time
• Career Level: Director