Associate Director, Clinical Operations Site Engagement Lead

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 meaningfully influence study strategy and execution.
• Identify emerging site-related risks, barriers, and opportunities early and mobilize the right stakeholders to address them.
• Drive strong cross-functional alignment and consistent execution of site engagement priorities across functions and geographies.
• Generate actionable insights that contribute to improved feasibility, site selection, recruitment, retention, and study execution.
• Improve the consistency, quality, and effectiveness of interactions between CSL and clinical research sites.
• Reduce unnecessary site burden and improve the overall site experience through practical, measurable improvements.
• Contribute to measurable improvements in study quality, timelines, efficiency, and cost.
• Strengthen CSL's reputation as a trusted, responsive, and collaborative partner to clinical research sites and investigators.

The expected base salary range for this position at hiring is $186,000 - $220,000/yr. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the Waltham, MA USA work location at the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

#LI-HYBRID

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor  visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.