Associate Director - Clinical Development, Oncology

Location: Indianapolis
Posted on: June 23, 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. At Lilly, we serve an outstanding purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. The Associate Director Clinical Development, Oncology independently leads the cross-functional study team in the development and execution of complex clinical trials and is accountable both regionally and globally to deliver clinical milestones on trials with quality, on time, and within scope and budget. The Associate Director consistently demonstrates leadership and influence throughout the trial process. Scope - Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make adjustments and changes (per change control process) as needed to meet the results of the trial. Timeline – Develop global trial enrollment plan by gaining alignment and integrating inputs across functions and geographies. Risk - Assess, identify and monitor trial-level risks. Incorporate knowledge, trial process, and expertise by creating a trial-level risk mitigation and contingency plan. Budget - Create and monitor trial budgets and assumptions using appropriate tracking tools. Routinely network with business partners on budget status and changes. Function as point of contact for peers as needed. Be accountable for trial/regional/program/molecule enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET) Find opportunities for trial improvements based on important trends such as industry, regulatory, new technology, etc. Manage TPO (third party organization) qualification process, selection, and oversight. Serve as the CRO (Clinical Research Organization) clinical development point of contact Clinical Trial Process Leadership and Expertise Leverage and demonstrate broad understanding of therapeutic, clinical drug development, and process expertise to influence study design and program-level decisions considering regional needs. Accountable for the Trial Master File for assigned trials, working closely with functional record owners to ensure the file is always current and inspection ready. Also ensuring on time delivery of documentation of deviations, creation of story boards or issue summary documents. (e.g. for high-risk areas/hot topics) Acts as a CDTL SME resource to peers and rollout of new tools, processes or methodologies to proceed as quickly as science allows. Detect and resolve quality issues, within (e.g., Medical Quality, Legal, Compliance, etc.) to arrive at the best solution. Minimum Qualification Requirements: Bachelor’s degree (ideally in a scientific or health-related field) Minimum 5 years clinical research or related experience Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position Preferences: Experience leading large clinical trials, preferably in oncology Ability to lead and work effectively cross-culturally with global colleagues and with TPOs, and be forward-thinking with organizational changes Proficiency in use of clinical trial systems (e.g.Veeva, MS Project, MS Excel, MS PowerPoint, PowerBI) Some travel required periodically to scientific and /or regional meetings 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

Keywords: , Lawrence , Associate Director - Clinical Development, Oncology, Science, Research & Development , Indianapolis, Indiana