Sr. Principal Specialist, Clinical Database Programming
Neurocrine Biosciences
August 30, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About The Role
Provides strategic and operational leadership for the clinical database programming function across Neurocrine’s clinical development portfolio. Hands-on role accountable for defining standards, governance, and long-term strategy for high-quality, compliant, scalable clinical databases. Acts as an expert influencing cross-functional decision-making and driving continuous improvement and inspection readiness.
Your Contributions (include, but are not limited to)
- Provide strategic leadership and functional ownership of clinical database programming across clinical programs and therapeutic areas
- Define, implement, and oversee standards, processes, and best practices for database programming (consistency, quality, regulatory compliance)
- Mentor, train, and develop team members (as required)
- Lead and perform database programming activities: database build; data review/cleaning; validation and derivation procedures; database migrations; Targeted SDV configuration; SAS dataset creation; Global Library maintenance
- Partner with Data Management and Analytics & Data Sciences (ADS) and cross-functional leadership on long-range plans, resourcing, and operating models
- Oversee database timelines, risks, dependencies; identify and mitigate technical/systemic issues impacting quality, inspection readiness, or submissions
- Oversee vendor quality/performance (CROs/consultants)
- Evaluate/implement/validate/adopt new technologies and system enhancements related to data collection, validation, integration, and review
- Assess impact of software updates to workflows; document findings/risks/recommended actions
- Ensure inspection readiness via proactive oversight of SOPs, work instructions, documentation practices, and quality metrics
- Liaise across Clinical Data Management (and ADS), Clinical Operations, DSPV, Regulatory, IT, and external partners
- Stay current with industry trends/regulatory expectations and translate insights into improvements
- Provide hands-on technical guidance in high-risk/high-complexity situations
Requirements
- BS/BA + 8+ years OR Master’s + 6+ years OR PharmD/PhD + 4+ years relevant experience
- Demonstrated cross-functional leadership without direct authority
- Strong leadership, communication, problem-solving, and decision-making skills
- Advanced Medidata Rave and clinical database programming experience in pharma/biotech (CRO or sponsor)
- Extensive end-to-end drug development and regulatory submission knowledge; GCP and FDA/EMA regulations
- CDISC experience (CDASH, SDTM) and organizational implementation
- Ability to define/govern SOPs and functional standards
- Advanced SAS and SQL (or other programming language)
- Experience with data visualization tools
- Experience leading enterprise-wide implementations or major upgrades
- Experience with custom programming (plus)
Benefits
- Annual bonus (target 30% of earned base salary) and eligibility for equity-based long-term incentive program
- Retirement savings plan (with company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and medical/prescription drug/dental/vision coverage
Provides strategic and operational leadership for the clinical database programming function across Neurocrine’s clinical development portfolio. Hands-on role accountable for defining standards, governance, and long-term strategy for high-quality, compliant, scalable clinical databases. Acts as an expert influencing cross-functional decision-making and driving continuous improvement and inspection readiness.
Your Contributions (include, but are not limited to)
- Provide strategic leadership and functional ownership of clinical database programming across clinical programs and therapeutic areas
- Define, implement, and oversee standards, processes, and best practices for database programming (consistency, quality, regulatory compliance)
- Mentor, train, and develop team members (as required)
- Lead and perform database programming activities: database build; data review/cleaning; validation and derivation procedures; database migrations; Targeted SDV configuration; SAS dataset creation; Global Library maintenance
- Partner with Data Management and Analytics & Data Sciences (ADS) and cross-functional leadership on long-range plans, resourcing, and operating models
- Oversee database timelines, risks, dependencies; identify and mitigate technical/systemic issues impacting quality, inspection readiness, or submissions
- Oversee vendor quality/performance (CROs/consultants)
- Evaluate/implement/validate/adopt new technologies and system enhancements related to data collection, validation, integration, and review
- Assess impact of software updates to workflows; document findings/risks/recommended actions
- Ensure inspection readiness via proactive oversight of SOPs, work instructions, documentation practices, and quality metrics
- Liaise across Clinical Data Management (and ADS), Clinical Operations, DSPV, Regulatory, IT, and external partners
- Stay current with industry trends/regulatory expectations and translate insights into improvements
- Provide hands-on technical guidance in high-risk/high-complexity situations
Requirements
- BS/BA + 8+ years OR Master’s + 6+ years OR PharmD/PhD + 4+ years relevant experience
- Demonstrated cross-functional leadership without direct authority
- Strong leadership, communication, problem-solving, and decision-making skills
- Advanced Medidata Rave and clinical database programming experience in pharma/biotech (CRO or sponsor)
- Extensive end-to-end drug development and regulatory submission knowledge; GCP and FDA/EMA regulations
- CDISC experience (CDASH, SDTM) and organizational implementation
- Ability to define/govern SOPs and functional standards
- Advanced SAS and SQL (or other programming language)
- Experience with data visualization tools
- Experience leading enterprise-wide implementations or major upgrades
- Experience with custom programming (plus)
Benefits
- Annual bonus (target 30% of earned base salary) and eligibility for equity-based long-term incentive program
- Retirement savings plan (with company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and medical/prescription drug/dental/vision coverage