Associate Director, Clinical Operations Site Engagement Lead

Key Responsibilities: Strategic Engagement & Study Leadership

• Develop, own, and continuously refine the engagement strategy for assigned programs and studies, aligned with program objectives and the broader CSL clinical development strategy.
• Establish and lead a cross-functional, program/study-specific Engagement Team, aligning stakeholders on engagement priorities, objectives, activities, and expected outcomes.
• Develop and drive proactive, purposeful, and actionable engagement plans across the full study lifecycle, from protocol concept and feasibility through study execution and close-out.
• Serve as the strategic voice of the site within CSL, bringing site perspectives, operational realities, and external intelligence into study and program decision-making.
• Translate site feedback, operational data, and external intelligence into actionable insights and recommendations that inform feasibility, site selection, recruitment, retention, study execution, and site experience.
• Use site intelligence to identify risks, barriers, and opportunities early, and constructively challenge assumptions, processes, and approaches where they may affect feasibility, site burden, quality, timelines, or study delivery.
• Align and influence stakeholders across functions and geographies to ensure site engagement priorities are embedded in study decisions and translated into action.
• Ensure site engagement is coordinated and consistent across CSL functions, providing sites with a seamless experience throughout the study lifecycle.
• Identify and drive opportunities to simplify processes, reduce unnecessary site burden, strengthen communication, and improve quality, efficiency, timelines, and cost.
• Capture and share lessons learned and site insights to strengthen future study planning, execution, and engagement approaches.

Site Relationships & External Engagement

• Build and maintain strong, trusted relationships with key institutions, investigators, and partner sites, positioning CSL as a responsive, collaborative, and valued partner.
• Develop a deep understanding of investigator and site needs, capabilities, challenges, and expectations across therapeutic areas, geographies, and healthcare systems.
• Engage proactively with sites to understand emerging operational trends, barriers, opportunities, and external developments that may influence clinical trial delivery.
• Establish effective and sustainable feedback mechanisms and communication pathways between sites and CSL, ensuring relevant insights are captured, connected to the right stakeholders, and acted upon.
• Use external relationships and site intelligence to identify opportunities for improving study feasibility, site experience, recruitment, retention, and execution.
• Champion the site perspective while balancing the needs of investigators, study teams, patients, and the broader business to deliver meaningful and sustainable outcomes.

Minimum Qualifications

• Advanced degree in life sciences, pharmacy, medicine, or a related health/scientific discipline.
• PhD, PharmD, MD, or equivalent advanced degree preferred.
• 10+ years of relevant experience in clinical research, clinical operations, medical affairs, site engagement, or a related discipline, with significant experience in global clinical development.
• Demonstrated experience working across the clinical trial lifecycle, with a strong understanding of the operational realities of clinical trial delivery.
• Significant experience working in a sponsor or CRO environment, ideally including experience within a pharmaceutical or biotechnology sponsor organization.
• Experience working internationally and across multiple geographies and cultures.
• Demonstrated ability to lead cross-functional teams and drive outcomes through influence rather than direct authority.
• Strong ability to analyze complex qualitative and quantitative information, identify meaningful patterns and insights, and translate them into clear recommendations for senior stakeholders.
• Excellent communication, presentation, relationship-building, and stakeholder-management skills.
• Strong proficiency in PowerPoint and Excel.
• Willingness and ability to travel regionally and internationally, up to approximately 30%.

Preferred Qualifications

• International Clinical Trial Management experience, ideally 4+ years.
• Experience in a fully outsourced or hybrid clinical trial operating model.
• Previous CRA experience.
• Experience in Clinical Development, Clinical Operations, Medical Affairs, MSL, Feasibility, Site Management, or related functions.
• Experience with Power BI, Smartsheet, or similar data visualization, analytics, and workflow-management tools.
• Experience engaging with investigators, academic institutions, research networks, or other clinical research stakeholders at a strategic level.

Leadership Capabilities

• Strategic thinking: Ability to see the bigger picture, connect information across functions and geographies, and translate strategy into practical action.
• Influence and leadership: Ability to build alignment, challenge constructively, and drive outcomes without relying on formal authority.
• External orientation: Genuine curiosity about the experience and needs of investigators and clinical research sites, with the ability to build trusted and productive relationships.
• Analytical thinking: Ability to combine data, site feedback, external intelligence, and operational experience to identify trends, risks, and opportunities and translate them into actionable insights.
• Execution focus: Tenacious, high-energy approach to turning recommendations into decisions, actions, and measurable outcomes.
• Cross-cultural collaboration: Proven ability to build productive partnerships across diverse cultures, functions, and geographies.
• Problem solving: Creative and pragmatic approach to solving complex problems in a dynamic environment.
• Credibility and integrity: Builds trust through sound judgment, transparency, follow-through, and a willingness to put program and study objectives first.
• Continuous improvement mindset: Consistently looks for opportunities to improve quality, simplify processes, reduce site burden, and enhance the clinical trial experience.