Executive Director, Clinical Trial Excellence and Patient Experience

15 hours ago

Cambridge, Massachusetts, United States Moderna Therapeutics Full time
The Role:

The Executive Director, Clinical Trial Excellence and Patient Experience, will lead key initiatives across Global Monitoring, RBQM (Risk-Based Quality Management), SSU (Study Start-Up) & Feasibility, Site Engagement & Support, Patient Recruitment & Retention, and Diversity in Clinical Trials.

This role is pivotal in driving operational excellence and innovation within Moderna's Clinical Development Operations portfolio, ensuring global trial efficiency and enhanced patient engagement.

This leader will shape and execute the vision for clinical trials, collaborating closely with the Chief Development Officer and the CDO LT to ensure scalability, flexibility, and compliance.

Key Responsibilities:
  • Lead the development of creative solutions in risk-based quality management and clinical data monitoring.
  • Champion strategic thinking and continuous improvement within trial monitoring operations.
  • Establish and lead a Feasibility Center of Excellence, collaborating with CROs to implement data-driven trial scenarios and drive innovation in feasibility processes.
  • Streamline and accelerate study start-up timelines.
  • Drive the design and implementation of patient recruitment and retention strategies that enhance patient and site experiences, contributing to optimized clinical trial outcomes.
  • Oversee global site engagement efforts to ensure strong partnerships with trial sites, emphasizing transparency, collaboration, and support for site personnel.
  • Implement strategies to increase diversity in clinical trials, ensuring representation across diverse populations and improving patient inclusion in studies.
  • Cultivate strong relationships across the organization and external partners, promoting operational alignment and ensuring effective trial execution.
  • Guide the Clinical Trial Excellence and Delivery team through growth and change, building new capabilities while fostering a culture of operational excellence and innovation.
Requirements:
  • Advanced degree (MSc, MBA, PhD, or equivalent) in life sciences, healthcare, or a related field is strongly preferred.
  • 12+ years of industry experience in Clinical Operations, including global clinical trials, study start-up, feasibility, patient recruitment, and retention.
  • 8+ years of leadership experience, demonstrating a proven ability to build and lead high-performing teams, with a focus on clinical trial optimization and innovation.
  • Strong knowledge of drug development processes, ICH-GCP guidelines, 21 CFR Part 11, and major Health Authority regulations.
  • Expertise in risk-based quality management and clinical trial monitoring.
  • Project management proficiency, with strong matrix leadership skills and a track record of accountability for deliverables.
  • Excellent interpersonal skills with a demonstrated ability to influence senior leadership and key stakeholders.
  • Ability to thrive in dynamic environments, showing resilience and flexibility to adapt to Moderna's entrepreneurial culture.
Leadership Behaviors:
  • Acts as a strategic thought leader and key partner within the Leadership Team, driving alignment across Clinical Development Operations.
  • Leads by example, balancing both high-level strategy and hands-on execution to achieve operational goals.
  • Demonstrates a deep commitment to fostering a culture of continuous improvement and innovation.
  • Adaptable and proactive in responding to the evolving needs of the organization, ready to build and scale new capabilities.
About Moderna:

Moderna is a leading biotechnology company that is pioneering the use of mRNA technology to develop novel therapeutics and vaccines. We are committed to improving the lives of patients and advancing the field of medicine.

We offer a comprehensive benefits package, including medical, dental, and vision coverage, as well as a 401(k) plan and paid time off. We also provide opportunities for professional growth and development, as well as a dynamic and inclusive work environment.

Moderna is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a workplace that is inclusive and respectful of all employees, and we strive to provide a work environment that is free from discrimination and harassment.

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