Senior Director, Investigator Engagement
hace 3 semanas
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
We welcome candidates from both Mexico and Brazil to apply for this role. Final determination of the position location will be subject to relevant country laws and applicable Lilly policy.
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 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.
Primary Responsibilities
- 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
- 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
- Drive to a culture of high quality and inspection readiness, as well as consistent utilization of data to inform decisions
People Management and Development
- Recruit, develop, and retain a scientific and technically capable workforce with clinical development and therapeutic knowledge necessary to effectively interact with clinical investigative sites within an assigned geography
- Effectively manage and coordinate an agile organization that continuously adapts to meet the needs of a changing portfolio
- Manage a diverse organization that fosters inclusion and innovation
- Develop a talent base that demonstrates judgment based decision making, and provides leadership in clinical delivery
Minimum Qualification Requirements
- Bachelor’s degree and minimum of 10 years of experience in the pharmaceutical industry and clinical research
- 3-5 years prior supervisory experience or equivalent
- Experience in, and/or leading different groups in drug development
- Broad understanding of pharmaceutical drug development process and experience in the planning and conduct of clinical research
Other Information/Additional Preferences
- Bachelor’s degree or Advanced degree (e.g. MSc, PhD) in a scientific or health care field
- Prior experience supervising an organization
- International or regional clinical operations experience
- Experience working across functions and affiliates
- Strong interpersonal skills, including capability to engage in professional relationship building and networking
- Proven ability to influence cross functionally without direct authority
- Proven ability to develop diverse organizational talent
- Ability to represent positions on difficult business issues
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 for further assistance.
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.
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