Associate Director, Clinical Operations Site Engagement Lead

CSL; Waltham (MA); On-site; USD 180,000 - 230,000; Full time

Job summary

CSL Plasma Inc. seeks an Associate Director, Site Engagement Lead to design and execute a strategic, cross-functional engagement plan for clinical programs, optimizing site feasibility, recruitment, and experience.

The role partners with Clinical Development, Trial Management, Site Management and Medical Affairs to align site perspectives with study goals, driving measurable improvements across the study lifecycle.

Qualifications

• Advanced degree in life sciences, pharmacy, medicine, or related field.
• 10+ years of experience in clinical research, clinical operations, medical affairs, site engagement, or related discipline.
• Experience across global clinical development; sponsor or CRO environments.

Responsibilities

• Develop and refine the engagement strategy for assigned programs and studies.
• Lead a cross-functional engagement team across the study lifecycle.
• Translate site feedback and external intelligence into actionable insights for feasibility, site selection and recruitment.
• Identify risks and opportunities; challenge assumptions affecting study feasibility and site experience.
• Collaborate across functions and geographies to ensure coordinated site engagement.

Skills

Strategic thinking

Influence without authority

Cross-functional collaboration

Analytical thinking

Execution focus

Stakeholder management

Communication

Travel up to 30%

Education

Advanced degree in life sciences/pharmacy/medicine

PhD/PharmD/MD or equivalent preferred

Tools

Power BI

Smartsheet

PowerPoint

Excel

Job description

The Associate Director, Site Engagement Lead is responsible for developing and executing a strategic, cross-functional engagement approach for assigned clinical programs and studies.**Work Environment:****\\*\\*\\* This is a hybrid position with a minimum of 3 days onsite required on a weekly basis. Relocation and mobility assistance are not provided.**The role serves as a **voice for clinical sites within CSL**, ensuring that site perspectives, operational realities, and external intelligence are translated into actionable insights that improve study feasibility, site selection, recruitment, retention, study execution, and the overall site experience.Working in close collaboration with Clinical Development, Clinical Trial Management, Site Management, Feasibility, Start-up, Medical Affairs, and other functions, the Associate Director, Site Engagement Lead builds trusted relationships with investigators and institutions while driving internal alignment, informed decision-making, and continuous improvement.The role requires an individual who can operate strategically while remaining close to operational realities, influence without direct authority, constructively challenge established approaches, and translate insights into meaningful and measurable outcomes.**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*** 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:**The successful candidate will demonstrate:* **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.**What Success Looks Like**Success in this role will be reflected in the ability to:* Establish trusted, productive, and mutually valuable relationships with investigators, institutions, and clinical research sites.* Ensure site perspectives and intelligence are consistently represented in CSL decision-making and