Head of Clinical Data Management

Neurocrine Biosciences • San Diego, CA

2d

About The Position

Provides enterprise-level leadership for the Clinical Data Management function and is accountable for the strategy, governance, operating model, and delivery of high-quality, inspection-ready clinical data across the clinical development portfolio. Ensures organizational capability, operational excellence, and scalable processes that support regulatory submissions, portfolio execution, and business objectives.

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

Nice To Haves

• Medidata Rave experience preferred

Responsibilities

• 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

Benefits

• annual bonus with a target of 35% of the earned base salary
• eligibility to participate in our equity based long term incentive program
• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior