Head of Clinical Data Management

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 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 LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)

About the Role:

_

Your Contributions (include, but are not limited to):

• Lead the Clinical Data Management function and/or major CDM sub-functions across the clinical development portfolio to ensure accurate, complete, timely, high-quality, and inspection-ready clinical trial data deliverables

• Establish and evolve the CDM strategy, operating model, governance framework, resource planning approach, vendor ecosystem, and capability roadmap to support portfolio growth and business priorities

• Provide portfolio-level strategic and operational leadership across the clinical data lifecycle, including data collection strategy, EDC/database build strategy, external data integration, data review, reconciliation, database lock readiness, clinical data delivery, and vendor oversight

• Drive execution quality and predictability across the portfolio by establishing data quality plans, risk-based approaches, portfolio metrics, dashboards, governance mechanisms, and escalation pathways

• Ensure CDM provides early strategic input into protocol design, CRF design, data standards, endpoint implementation, data flow, and cross-study consistency to enable fit-for-purpose data collection and high-quality analysis-ready data

• Partner with senior leaders in Biostatistics and Statistical Programming to drive end-to-end traceability from protocol and CRF design through SDTM-ready and analysis-ready data, reducing downstream rework and improving analysis timelines

• Lead resolution of high-impact or cross-functional CDM issues, including data quality risks, database lock risks, external data reconciliation challenges, vendor performance concerns, submission-readiness issues, and process or operating model gaps

• Establish and oversee CRO, vendor, contractor, and external data provider governance models; ensure vendor strategy, performance, quality, timelines, issue resolution, and contractual deliverables support portfolio needs

• Represent CDM in senior cross-functional governance, portfolio, program, vendor, and operational forums; communicate risks, recommendations, decisions, tradeoffs, and progress to senior leadership

• Partner with Clinical Development, Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety/PV, Regulatory, Quality, Clinical Systems/IT, and external partners to align CDM strategy with development priorities, regulatory expectations, program goals, and business needs

• Own development and continuous improvement of CDM processes, standards, templates, work practices, governance mechanisms, and quality frameworks to increase operational efficiency, inspection readiness, and consistency across the portfolio

• Lead CDM technology enablement and modernization strategy, including scalable EDC build approaches, standard libraries, reusable CRFs/edit checks, automation, AI-enabled data review workflows, data quality surveillance, and solutions supporting end-to-end biometrics standardization

• Ensure the CDM function operates 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

• Provide senior leadership for CDM-related inspections, audits, quality reviews, data integrity initiatives, submission-readiness activities, and corrective/preventive action plans

• Build, lead, and develop a high-performing CDM organization; manage leaders and/or senior professionals, strengthen role clarity, decision quality, accountability, empowerment, career development, and succession planning.

• Own or provide senior-level input into resource planning, budget planning, vendor proposal review, staffing strategy, outsourcing strategy, and timeline planning for the CDM function or assigned portfolio

• Monitor industry trends, technologies, data standards, outsourcing models, and evolving regulatory expectations related to CDM; identify and lead strategic process, system, or operating model improvements

• Perform other duties as assigned

Requirements:

• BS/BA degree in Computer Science, life science, or related field AND 14+ in Clinical Data Management in a biopharmaceutical setting (industry and/or CRO OR

• Master's degree in Computer Science, life science or related field AND 12+ years of similar experience noted above OR

• PhD in Computer Science, life science or related field AND 10+ years of similar experience noted above

• Senior leadership experience in Clinical Data Management across multiple clinical programs, development phases, and/or therapeutic areas in the biotechnology, pharmaceutical, or CRO environment

• Strong working knowledge of the clinical data lifecycle, including data collection strategy, CRF design, EDC/database build strategy, external data integration, data review, reconciliation, database lock, regulatory submission readiness, and clinical data delivery

• Demonstrated ability to establish or evolve CDM strategy, operating model, governance frameworks, standards, resource planning, vendor strategy, and leadership capability for a growing clinical development portfolio

• Strong working knowledge of EDC platforms and related CDM systems; Medidata Rave experience preferred

• Deep experience with clinical data standards, including CDASH, SDTM, controlled terminology, standard CRF libraries, global libraries, reusable edit checks, and cross-study standardization

• Demonstrated ability to partner with senior leaders in Biostatistics and Statistical Programming to drive fit-for-purpose data collection, end-to-end traceability, biometrics standardization, and analysis-ready data delivery

• Proven experience establishing and overseeing CROs, vendors, contractors, and external data providers in outsourced or hybrid operating models

• Deep knowledge of GCP, ICH guidelines, regulatory expectations, data integrity principles, SOPs, inspection-readiness requirements, and submission-supporting data expectations

• Experience establishing portfolio-level CDM metrics, dashboards, and governance mechanisms to drive quality, predictability, vendor performance, cycle time reduction, and database lock readiness

• Demonstrated ability to lead functional transformation, process improvement, technology enablement, and modernization efforts, including scalable EDC build approaches, standard libraries, automation, AI-enabled data review workflows, data visualization, and/or data quality surveillance

• Strong people leadership experience, including leading leaders, developing senior professionals, building high-performing teams, and strengthening succession planning

• Strong executive communication, influence, collaboration, decision-making, and stakeholder management skills in a fast-paced, matrixed environment

• Demonstrated ability to lead through ambiguity, align cross-functional stakeholders, manage competing priorities, and make sound tradeoff decisions that support portfolio and business objectives

#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.

_