Brief Description

Accountable to Global Clinical Development Operations (GCDO) for the strategies, tools, and expertise to ensure effective, efficient, and compliant oversight of clinical trials across the Jazz portfolio.  Develops and drives the adoption of risk-proportionate, data-driven approaches to ensuring quality in in-house, hybrid, and outsourced Sponsored clinical trials.

Key areas of focus include overseeing the implementation of data-driven, modernized clinical trial risk-based quality management and centralized monitoring function, and management and oversight of the global site monitoring function.

Essential Functions/Responsibilities

• Accountable leader over GCDOs Risk-Based Quality Management (RBQM) strategy, framework (quality risk management plans, risk assessment, and escalation), and execution within Jazz Sponsored internally supported/hybrid and outsourced clinical trials.

• Develop and implement appropriate data-driven monitoring strategies (central, remote, on-site) including establishing centralized analytics, dashboards, and KRIs/QTLs to support issue detection and decision-making with regulatory guidance (ICH E6 R2/3, FDA and EMA expectations).

• Lead and manage the Trial Risk Management, Site Monitoring, and Central Monitoring functions and teams across both outsourced and internally supported/hybrid trials, ensuring appropriate, risk-proportional monitoring approaches (on-site, central, remote) are executed with consistency against Jazz standards.

• Manage and hold accountable internal resources and external partners’ performance of trial risk management, central monitoring, and  remote/on-site monitoring activities ensuring consistency and quality in delivery against KPIs and standards.

• Support regulatory inspections and internal audits as an SME for the RBQM and site monitoring functions.

• Partner with cross-functional leadership (Clinical Operations, Business and Technology Capabilities, R&D Process and Training, etc.)  on the evaluation, implementation, and continuous improvement of technology systems and business processes supporting compliance and efficiency in quality risk management and trial oversight.

• Provide leadership and mentorship to staff supporting corporate, R&D, and functional goals and individual employee development and succession planning.

• Represent GCDO on critical cross-functional initiatives for business process improvement and innovation in risk-proportionate approaches to monitoring and quality risk management for new/novel trial designs and operational approaches.

• Leadership representation at the RBQM, Central and Site Monitoring functions at governance meetings with external partners, as required.

• Demonstrate internal and external technical expertise and thought leadership in innovative risk-based and centralized approaches to quality oversight in clinical trials.

• Constructively challenge the status quo integrating an externally focused perspective with deep knowledge of emerging risks and opportunities in the landscape for AI/technology, regulatory, and leading industry practice for risk management, quality oversight, and monitoring

• Partner with other site-facing functions and business units (GPSE, Medical Affairs, Commercial) to build positive association and awareness to the Jazz brand through ensuring clarity, consistency, and coordination in Jazz all investigator site encounters and interactions.

• Champion a culture willing to innovate and continually improve to accelerate the development of medicines for patients and their caregivers with unmet needs.

Required Knowledge, Skills, and Abilities

• Expert knowledge of RBQM and current leading practices for risk-proportionate monitoring and oversight of clinical trials (i.e. central monitoring, risk-based monitoring).

• Extensive knowledge and experience in the pharmaceutical industry, specifically with experience in clinical operations, clinical project management, consulting and change management.

• Fluent in AI with proven experience developing and applying AI-enabled tools in clinical trial operations and related use cases.

• Demonstrated expertise interpreting and applying GCP guidance and regulation.

• Fluent in data analytics and use of data-driven approaches to manage risk and guide decision-making.

• Strong business acumen to integrate operational excellence and financial stewardship into strategies and pull through execution.

• Experience forming and leading high-performing teams and fostering positive team culture.

• Excellent communication skills (written/verbal) with demonstrated ability to adapt to communicating to all levels of leadership across functions.

• Enthusiasm for tackling complex problems in a dynamic, high-growth organization.

• Experience with consultative selling a plus.

Required/Preferred Education and Licenses

• Bachelor’s degree required; advanced degree preferred.

• Experience in pharmaceutical/biotechnology required.

• Management experience required.

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