Head of Clinical Data Management

Who We Are

Neurocrine Biosciences is a leading biopharmaceutical company dedicated to developing life‑changing treatments for patients with under‑addressed neurological, psychiatric, endocrine and immunological disorders. The company offers FDA‑approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader‑Willi syndrome, endometriosis and uterine fibroids, and maintains a robust pipeline of compounds in mid‑ to late‑phase clinical development.

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 a senior leader within the function based on organizational needs.

• 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…