Associate Director, Data Monitoring Committee (DMC) Expert

Company: Eli Lilly and Company
Location: Indianapolis
Posted on: June 24, 2025

Job Description:

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. Purpose: The purpose of the Associate Director, DMC Expert role is to provide technical leadership and support in the design, development, delivery, and management of Lilly’s Data Monitoring Committees (DMCs) and Assessment Committees (ACs). This role is crucial in ensuring patient safety, data integrity, and regulatory compliance through effective DMC operations. This position will work closely with leadership and stakeholders to support decision-making and execution that aligns with the company’s core values and objectives. Primary Responsibilities : Strategic Support Assist in establishing and providing direction for a standardized DMC/AC framework and policy for clinical trials, ensuring compliance with regulatory guidelines such as FDA, EMA, and ICH/GCP. Support the development and implementation of standardized DMC/AC charter templates and operational procedures, including meeting schedules, data presentation formats, and conflict of interest policies. Collaborate with other DMC experts, medical, clinical development, statistics teams, vendors, and other stakeholders to ensure seamless integration of DMC activities. Implement quality control measures for DMC/AC processes to ensure consistency and effectiveness, such as conducting audits and reviews of DMC performance. Technical Expertise Review and provide expert advice to study teams on the necessity and design of DMCs for various clinical trials, particularly during the protocol development stage. Provide consultation with medical and clinical development teams on integrating DMC activities into trial protocols and overall development strategies, ensuring alignment with ethical and scientific standards. Ensure regulatory compliance, staying updated on guidelines and regulations. Prepare and present comprehensive reports on DMC/AC activities to senior management and other stakeholders to ensure transparency. Vendor Management Standards Establish and manage framework for effective Statistical Analysis Center (SAC) vendor management in defining good oversight and measures for monitoring to ensure compliance for DMCs/ACs Review and advise on contract development. Shared Learning and Continuous Improvement Communicate, train, and influence teams for proper adoption of the standardized DMC/AC framework Focus on organizational learning to proactively identify, apply, and share best practices and learnings related to DMC governance and protocol design within and outside the organization. Closely collaborate with asset teams and delivery teams to understand the impact of design on speed to protocol approval and study startup. Work closely with counterparts in Medical, clinical, statistics and therapeutic areas to generate ideas and continue to evolve Lilly standards, tools, and best practices. Collaborate Effectively Externally and Internally Develop and influence relationships with external parties, Lilly cross-functional teams consistent with Team Lilly behaviors Guide study teams regarding contract agreements Train staff on DMC/AC processes Participate and support audits and inspections (internal, external party, or regulator audits and inspections) Minimum Qualification Requirements: Bachelor’s degree in healthcare, pharmacy, biostatistics or a related field Five years of experience in the pharmaceutical industry or related healthcare environment. Other Information/Additional Preferences: Experience in serving or managing Data Monitoring Committees Experience in clinical practice, clinical research or pharmaceutical medicine and the drug development process. Knowledge of external guidelines, regulations, and public policy related to research and development. Demonstrated ability to network internally and influence at multiple levels and across multiple functions. Demonstrated strong verbal and written communication skills. Excellent organizational, administrative, and interpersonal skills. Demonstrated capabilities in driving change. Strong strategic thinking skills. Demonstrated ability to apply relevant information, look for opportunities, and effectively influence the direction of a program. Communication skills in complex clinical trial environments Some travel may be required (0 - 5%) 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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $111,000 - $162,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. WeAreLilly

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