Clinical Research Lead

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Overview

The Clinical Research Lead (CRL) is responsible for managing clinical investigators and sites participating in Lilly clinical trials and/or Post-Marketing Safety Studies. This includes investigator/site identification and qualification, ensuring timely trial enrollment aligned with scientific objectives, database lock delivery, issue resolution at trial sites, and maintaining inspection readiness at all times.

The CRL ensures global program delivery through comprehensive investigator and site management, leveraging data and tools for informed decisions, and fostering high-quality interactions with clinical trial sites to provide an unparalleled customer experience. Additionally, the CRL oversees vendor monitoring activities, identifying and mitigating significant findings and trends.

In countries without an Associate Director/Director of Investigator Engagement, the CRL may represent Investigator Engagement internally and externally, including interactions with regulatory bodies and influencing the local regulatory environment and strategy.

Primary Responsibilities

Clinical Investigator Management

• Manage all activities at clinical trial sites, including site identification, qualification, enrollment planning, execution, and close-out.
• Ensure timely delivery of enrollment readiness, trial recruitment, and database locks through performance management and issue resolution.
• Identify opportunities to accelerate trial enrollment while maintaining an exceptional customer experience.
• Apply scientific, therapeutic area, and regional expertise to support trial execution and quality data delivery.
• Develop strategic institutional/site relationships to optimize clinical trial programs across therapeutic areas.

Clinical Trial Management

• Implement investigator/site risk plans to meet enrollment and database lock commitments.
• Maintain site and country-level inspection readiness at all times.
• Use metrics to inform site/country/regional decision-making.
• Collaborate with internal and external teams to remove barriers to trial execution.
• Understand local treatment paradigms and standard of care to support feasibility and trial allocation.
• Provide vendor oversight for site monitoring activities.
• For countries with PMS requirements: manage Post-Marketing Safety Studies, including CRO selection, regulatory documentation, and project management.

Business Management and Engagement

• Build strong professional relationships with clinical investigators to expand research partnerships and deliver an exceptional trial experience.
• Collaborate cross-functionally to align priorities and deliver the portfolio.
• Prospect targeted sites in line with portfolio strategy.
• Maintain therapeutic and technical expertise for scientific discussions with investigators and site staff.
• Act as a communication bridge between sites, vendors, and Lilly.
• Influence internal and external factors to improve clinical research delivery.

Country/Regulatory Responsibilities (where applicable)

• Engage with regulatory bodies, ethical review boards, and national authorities to represent Lilly in the clinical trial environment.
• Participate in country pharmaceutical associations and affiliated bodies.
• Ensure compliance with local regulatory requirements and maintain internal processes accordingly.
• Contribute to external clinical development community initiatives and incorporate learnings into internal strategies.
• Support affiliate leadership in implementing regional initiatives.

Minimum Qualifications

• Bachelor’s degree or equivalent (preferably in a scientific or health-related field).
• Minimum 3 years of experience in pharmaceutical industry and/or clinical research.
• Strong knowledge of Good Clinical Practice (GCP).
• Ability to acquire and maintain therapeutic expertise to support portfolio needs.
• Excellent organizational and self-management skills.
• Strong communication skills (verbal and written) and ability to influence others.
• Strategic agility and broad business acumen.
• Demonstrated leadership behaviors and ability to lead in uncertain environments.

Additional Preferences

• Strong organizational and planning skills.
• Ability to enhance customer experience.
• Fluent in English.
• Knowledge of country regulatory guidelines.
• Strong teamwork and interpersonal skills.
• Ability to develop innovative solutions.
• Travel required (50–75%).

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly