Senior Director, Trial Risk Management & Monitoring in United States at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Director, Trial Risk Management & Monitoring in United States.

This senior leadership role is responsible for defining and driving enterprise-wide strategies for clinical trial risk management, ensuring the highest standards of quality, compliance, and operational excellence across global studies. The position plays a critical role in shaping modern, data-driven approaches to trial oversight, integrating centralized and risk-based monitoring methodologies across complex clinical programs. You will lead global teams responsible for trial risk management, centralized monitoring, and site monitoring activities across both outsourced and internally managed studies. The role requires close collaboration with cross-functional R&D, clinical operations, and technology teams to implement innovative systems, analytics, and processes that enhance trial quality and efficiency. You will also serve as a key expert supporting regulatory inspections, audits, and governance discussions with internal and external stakeholders. This is a highly strategic and influential position driving transformation in clinical trial execution and quality oversight at scale.

• Lead the global strategy, framework, and execution of Risk-Based Quality Management (RBQM) across all sponsored clinical trials, including hybrid and outsourced models.
• Design and implement advanced data-driven monitoring strategies, including centralized analytics, dashboards, and key risk indicators to support proactive decision-making.
• Oversee global Trial Risk Management, Central Monitoring, and Site Monitoring functions, ensuring consistent application of risk-proportionate oversight methodologies.
• Manage internal teams and external partners, ensuring performance against established KPIs, quality standards, and regulatory expectations.
• Act as a subject matter expert during regulatory inspections and internal audits related to RBQM and monitoring activities.
• Collaborate with cross-functional stakeholders to evaluate and implement technologies, systems, and processes that improve trial oversight and compliance.
• Lead continuous improvement initiatives focused on innovation in risk-based monitoring and quality management practices.
• Represent the function in governance forums, external partnerships, and strategic cross-functional initiatives.
• Drive alignment across clinical operations, medical affairs, and site-facing teams to ensure consistency in investigator engagement and trial execution.
• Foster a culture of innovation, accountability, and data-driven decision-making across clinical trial operations.

• Bachelor’s degree required; advanced degree preferred in life sciences, pharmacy, or related field.
• Extensive experience in the pharmaceutical or biotechnology industry, particularly in clinical operations or clinical development.
• Deep expertise in Risk-Based Quality Management (RBQM), centralized monitoring, and risk-proportionate clinical trial oversight.
• Strong knowledge of ICH-GCP guidelines and global regulatory expectations (FDA, EMA).
• Proven experience applying data analytics and AI-enabled tools to clinical trial operations or related functions.
• Demonstrated leadership experience managing large, global, cross-functional teams.
• Strong ability to interpret complex data and translate insights into operational strategies.
• Excellent communication and stakeholder management skills across all organizational levels.
• Strong business acumen with the ability to balance operational excellence, compliance, and financial considerations.
• Experience in change management and driving innovation in complex, regulated environments.

• Competitive executive-level compensation with a base salary range of $230,400 – $345,600 annually.
• Eligibility for annual performance-based bonuses or incentive compensation.
• Long-term equity incentive opportunities depending on role eligibility.
• Comprehensive healthcare coverage including medical, dental, and vision insurance.
• Retirement savings plan with employer contributions.
• Flexible paid time off and generous vacation policies.
• Remote work flexibility with global collaboration opportunities.
• Professional development opportunities within a science-driven, innovation-focused environment.
• Strong emphasis on employee well-being and work-life balance.