Senior Director, Investigator Engagement

hace 3 meses

Ciudad de México CDMX Lilly A tiempo completo

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.

Senior Director, Investigator Engagement

Purpose:
The Senior Director / Executive Director, Investigator Engagement is accountable for ensuring high quality interactions with, and timely robust performance of, global clinical trial sites both within an assigned therapeutic area and a defined region. This includes overall compliance with GCPs and applicable regulations, collaboration in achieving clinical trial goals, and inspection readiness. The Senior Director / Executive Director, Investigator Engagement will effectively leverage, and oversee regional vendor performance of delegated responsibilities, and will identify, investigate, and drive issue resolution. The Senior Director / Executive Director, Investigator Engagement will be responsible for working with Design Hub and Clinical Development representatives to ensure effective and efficient processes and development of necessary deliverables in transition from clinical design to implementation. The role provides leadership in committing and delivering to clinical trial recruitment targets that enable industry leading cost and cycle time performance metrics. The Senior Director / Executive Director, Investigator Engagement is also responsible for the recruitment, training, and development of staff who are responsible for comprehensive site management, inclusive of the delivery of site performance metrics, on time database locks, inspection readiness and leveraging their regional and scientific expertise to achieve these results. Additional local responsibilities may be required as needed/appropriate for the local geography, and/or to cover any regional differences.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Clinical Investigator Management
- Responsible for clinical site / Investigator qualification and recruitment performance
- Deliver global enrollment commitments across the portfolio of work within a therapeutic area(s) and region(s)
- Ensure productive relationships with investigator sites
- Ensures objective input from field staff into strategic allocation of trials within and across regions
- Maintain awareness of global regulatory requirements and ensure activities are performed according to established guidelines, best practices, and in compliance with all appropriate laws
- Responsible for appropriate integration, delivery, oversight and issue mitigation/resolution of comprehensive site monitoring activities within a region and integrated across regions
- Ensure on time delivery of data base locks, and inspection readiness within a therapeutic area(s) and region(s)

Organizational Leadership
- Support flexibility of resources across therapeutic areas and geographies, while aligning to deliver on company portfolio priorities
- Responsible for the development and implementation of applicable site risk plans to ensure delivery of clinical trial enrollment commitments and data base locks
- Serve as liaison between clinical trial sites, third party vendors, and Lilly
- Function as the global Investigator engagement point of contact for an assigned therapeutic area, as well as the primary Investigator engagement leader within a specified geography
- Identify and ensure shared learning across the Investigator engagement organization and with other CDO functional groups
- Enable a culture of continuous improvement to drive efficiency through therapeutic area knowledge, process improvement, quality and risk management capabilities, people knowledge and clinical development expertise, and shared learning
- Responsible for applicable Investigator engagement project management activities necessary to support the delivery of clinical trials within a therapeutic area(s) and regio
- Drive to a culture of high quality and inspection readiness, as well as consistent utilization of data to inform decisions

Engage in the external global clinical development community to influence external environmental improvements and drive the incorporation of external learnings into internal continuous improvement efforts

People Management and Deve

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