_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 patients with 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 , Facebook and YouTube. (_*in collaboration with AbbVie_)
About the Role:
Provides strategic and operational leadership for clinical data management activities across multiple clinical programs to deliver high-quality, inspection-ready clinical data supporting clinical development, regulatory submissions, and business decision-making. May function as the lead for Clinical Data Management or as a senior leader within the function based on organizational needs.
Accountable for overall Clinical Data Management strategy, operating model, budget and resource planning, vendor ecosystem, and development of leadership capability within the function when serving in a functional leadership capacity.
Ensures execution quality across the clinical data lifecycle, including data collection strategy, EDC/database build, external data integration, data review, reconciliation, database lock readiness, and vendor oversight. Establishes data quality plans, operational metrics, and risk-based approaches to improve predictability, reduce rework, and ensure timely delivery of reliable clinical data.
Collaborates cross-functionally to enable fit-for-purpose data collection, cross-study consistency, and end-to-end traceability from protocol and CRF design through analysis-ready datasets. Leads continuous improvement and technology enablement initiatives, including scalable EDC build methodologies, standard libraries, automation, AI-enabled data review workflows, and solutions supporting end-to-end biometrics standardization.
Manages and develops internal staff and external partners, strengthening leadership capability within the function while ensuring effective resource planning, vendor governance, and succession planning.
Your Contributions (include, but are not limited to):
- Direct clinical data management activities across assigned studies, programs, and/or sub-functional areas to ensure accurate, complete, timely, high-quality, and inspection-ready clinical trial data deliverables
- Provide strategic and operational leadership across the clinical data lifecycle, including data collection strategy, EDC/database build, external data integration, data review, reconciliation, database lock readiness, and clinical data delivery
- Lead development and execution of key CDM deliverables, including data management plans, data review plans, database specifications, edit check specifications, query management processes, quality review activities, database audits, and database lock plans
- Provide early strategic input into protocol design, CRF design, data standards, endpoint implementation, and cross-study consistency to enable fit-for-purpose data collection and high-quality analysis-ready data
- Partner with Biostatistics and Statistical Programming to support end-to-end traceability from protocol and CRF design through SDTM-ready and analysis-ready data, reducing downstream rework and improving analysis timelines.
- Establish and monitor CDM metrics, dashboards, and governance mechanisms to track data quality, query trends, vendor performance, cycle times, reconciliation status, lock readiness, and milestone achievement
- Direct identification, escalation, and resolution of complex CDM issues, including data quality trends, database discrepancies, external data reconciliation challenges, vendor performance concerns, and cross-functional process risks.
- Oversee CROs, vendors, contractors, and other external partners supporting CDM activities; monitor performance, deliverables, quality, timelines, issue resolution, and compliance with contractual and regulatory expectations
- Represent CDM in cross-functional governance, study team, program team, vendor, and operational meetings; communicate risks, recommendations, decisions, and progress to senior leadership
- Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety/PV, Regulatory, Quality, Clinical Systems/IT, and external vendors to align CDM activities with study timelines, regulatory expectations, program goals, and business needs
- Develop and improve CDM processes, standards, templates, work practices, and governance mechanisms to increase operational efficiency, inspection readiness, quality, and consistency across studies and programs.
- Lead or contribute to technology enablement and modernization efforts, including scalable EDC build approaches, standard libraries, reusable CRFs/edit checks, automation, AI-enabled data review workflows, and solutions that support end-to-end biometrics standardization
- Ensure CDM activities are conducted in accordance with applicable regulations, Good Clinical Practice, ICH guidelines, Good Clinical Data Management Practices, SOPs, work instructions, data integrity expectations, and study-specific requirements. Lead or contribute to CDM-related inspections, audits, quality reviews, data integrity initiatives, and corrective/preventive action activities, as applicable
- Provide leadership, coaching, performance feedback, and development support to CDM employees, contractors, and matrixed team members; may manage through subordinate leaders or oversee indirect teams
- Support resource planning, budget input, vendor proposal review, staffing strategy, timeline planning, leadership capability development, and succession planning for assigned studies, programs, or sub-functional areas. Monitor industry trends, technologies, data standards, and evolving regulatory expectations related to CDM; recommend and lead appropriate process, system, or operating model improvements
- Perform other duties as assigned
Requirements:
- BS/BA degree and 12+ years of relevant experience OR
- Masters and 10+ years of related experience OR
- PhD and 8+ years of related experience
- Extensive experience leading Clinical Data Management activities across multiple clinical studies and programs in the biotechnology, pharmaceutical, or CRO environment
- Strong knowledge of the clinical data lifecycle, including data collection strategy, CRF design, EDC/database build, external data integration, data review, reconciliation, database lock, and clinical data delivery
- Strong working knowledge of EDC platforms and related CDM systems; Medidata Rave experience preferred
- Experience with clinical data standards, including CDASH, SDTM, controlled terminology, standard CRF libraries, and cross-study standardization
- Demonstrated ability to partner with Biostatistics and Statistical Programming to enable fit-for-purpose data collection, end-to-end traceability, and analysis-ready data
- Proven experience overseeing CROs, vendors, contractors, and external data providers in outsourced or hybrid operating models
- Knowledge of GCP, ICH guidelines, regulatory expectations, data integrity principles, SOPs, and inspection-readiness requirements
- Experience establishing and monitoring CDM metrics and dashboards to drive quality, predictability, vendor performance, and database lock readiness
- Demonstrated ability to lead process improvement, technology enablement, and modernization efforts, including scalable EDC build approaches, standard libraries, automation, AI-enabled data review workflows, and/or data visualization tools
- Strong people leadership experience, including coaching, developing, and managing CDM employees, contractors, or matrixed team members; experience managing through subordinate leaders preferred
- Strong communication, collaboration, problem-solving, decision-making, and stakeholder management skills in a fast-paced, matrixed environment
#LI-KM1
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.
