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 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 performanceDeliver global enrollment commitments across the portfolio of work within a therapeutic area(s) and region(s)Ensure productive relationships with investigator sitesEnsures objective input from field staff into strategic allocation of trials within and across regionsMaintain awareness of global regulatory requirements and ensure activities are performed according to established guidelines, best practices, and in compliance with all appropriate lawsResponsible for appropriate integration, delivery, oversight and issue mitigation/resolution of comprehensive site monitoring activities within a region and integrated across regionsEnsure 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 prioritiesResponsible for the development and implementation of applicable site risk plans to ensure delivery of clinical trial enrollment commitments and data base locksServe as liaison between clinical trial sites, third party vendors, and LillyFunction as the global Investigator engagement point of contact for an assigned therapeutic area, as well as the primary Investigator engagement leader within a specified geographyIdentify and ensure shared learning across the Investigator engagement organization and with other CDO functional groupsEnable 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 learningResponsible for applicable Investigator engagement project management activities necessary to support the delivery of clinical trials within a therapeutic area(s) and regioDrive 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 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 geographyEffectively manage and coordinate an agile organization that continuously adapts to meet the needs of a changing portfolioManage a diverse organization that fosters inclusion and innovationDevelop a talent base that demonstrates judgment based decision making, and provides leadership in clinical delivery

Minimum Qualification Requirements:  

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.Bachelor's degree and minimum of 10 years of experience in the pharmaceutical industry and clinical research3-5 years prior supervisory experience or equivalentExperience in, and/or leading different groups in drug developmentBroad 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 heath care fieldPrior experience supervising an organizationInternational or regional clinical operations experienceExperience working across functions and affiliatesStrong interpersonal skills, including capability to engage in professional relationship building and networkingProven ability to influence cross functionally without direct authorityProven ability to develop diverse organizational talentAbility 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 (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.

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