_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 (formerly Twitter) 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, IT, and external partners
- Stay current with industry trends and regulatory expectations; translate insights into actionable improvements for Neurocrine
- Provide hands-on technical guidance and expertise in high-risk or high-complexity situations to ensure database quality and an appropriate resolution.
- other duties as assigned
_Requirements:_
- BS/BA degree AND 8+ years of relevant experience OR
- Master’s AND 6+ years of related experience OR
- PharmD or PhD AND 4+ years of related experience
- Demonstrated success as a leader and influencing cross-functional teams without direct authority
- Strong leadership, communication, problem-solving, and decision-making skills
- Anticipates business and industry issues; recommends relevant process / technical / service improvements
- Demonstrates broad expertise or unique knowledge
- Considered an expert within the company and may have external presence in area of expertise
- Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team
- Ability to work as part of and lead multiple teams
- Strong leadership, mentoring skills and abilities; typically leads lower levels and/or indirect teams
- Excellent computer skills
- Excellent communications, problem-solving, analytical thinking skills
- Sees broader picture and longer-term impact on division/company
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
- Excellent project management, strong project leadership skills
- Advanced 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 requirements
- Expert knowledge of GCP and applicable FDA/EMA regulations and guidance
- Demonstrated experience with CDISC standards (CDASH, SDTM) and organizational implementation of standards
- Proven ability to define and govern SOPs, work instructions, and functional standards across the organization
- Advanced hands-on experience with clinical database programming tools, including SAS and SQL (or other programming language)
- Experience with data visualization tools
- Experience leading enterprise-wide system implementations or major upgrades
- Experience with custom programming a plus
#LI-RS1
Neurocrine 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.
