About The RoleProvides 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 areasDefine, implement, and oversee standards, processes, and best practices for database programming to ensure consistency, quality, and regulatory complianceMentor, 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 objectivesOversee database timelines, risks, and dependencies; proactively identify and mitigate complex technical/systemic issues that could impact quality, inspection readiness, or submissionsOversee vendor quality and performance, including CROs and consultants, ensuring alignment with internal standards and expectationsLead evaluation, implementation, validation, and adoption of new technologies, platforms, and system enhancements related to data collection, validation, integration, and reviewAssess the impact of and oversee software updates, including impact to team processes and workflows, and document findings, risks, and recommended actionsEnsure inspection readiness and regulatory compliance through proactive oversight of SOPs, work instructions, documentation practices, and quality metricsAct as a liaison across Clinical Data Management (and ADS), Clinical Operations, DSPV, Regulatory, IT, and external partnersStay current with industry trends and regulatory expectations; translate insights into actionable improvements for NeurocrineProvide hands-on technical guidance and expertise in high-risk or high-complexity situations to ensure database quality and an appropriate resolution.Other duties as assignedRequirements:BS/BA degree AND 8+ years of relevant experience ORMaster's AND 6+ years of related experience ORPharmD or PhD AND 4+ years of related experienceDemonstrated success as a leader and influencing cross-functional teams without direct authorityStrong leadership, communication, problem-solving, and decision-making skillsAnticipates business and industry issues; recommends relevant process / technical / service improvementsDemonstrates broad expertise or unique knowledgeConsidered an expert within the company and may have external presence in area of expertiseApplies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of teamAbility to work as part of and lead multiple teamsStrong leadership, mentoring skills and abilities; typically leads lower levels and/or indirect teamsExcellent computer skillsExcellent communications, problem-solving, analytical thinking skillsSees broader picture and longer-term impact on division/companyAbility to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiencyExcellent project management, strong project leadership skillsAdvanced knowledge of Medidata Rave and clinical database programming within a pharmaceutical or biotechnology environment (CRO or sponsor)Extensive understanding of the end-to-end drug development process and regulatory submission requirementsExpert knowledge of GCP and applicable FDA/EMA regulations and guidanceDemonstrated experience with CDISC standards (CDASH, SDTM) and organizational implementation of standardsProven ability to define and govern SOPs, work instructions, and functional standards across the organizationAdvanced hands-on experience with clinical database programming tools, including SAS and SQL (or other programming language)Experience with data visualization toolsExperience leading enterprise-wide system implementations or major upgradesExperience with custom programming a plusNeurocrine Biosciences is an EEO/Disability/Vets employer.We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.The annual base salary we reasonably expect to pay is $158,100.00-$216,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program.
Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.