Associate Director – Clinical Trial Foundations

Eli Lilly

  • Indianapolis, IN
  • $111,000-162,800 per year
  • Permanent
  • Full-time
  • 1 day ago
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 Associate Director, Clinical Trial Foundations (CTF), will serve as the subject matter expert for clinical systems supporting clinical development. In this role, you will define and execute implementation plans to deliver on the system strategies, integrations and improvements. The focus of this role will be to support data collection systems, primarily focused on EDC and data aggregation systems, and assisting the team to prepare for inspections. The Associate Director is responsible for collaborating with business partners to enable development, implementation and support of streamlined, clear and compliant systems to support clinical development. This role will also work closely with external parties including vendors, industry authorities and related organizations to optimize Lilly’s capabilities to support business and customer-focused, efficient clinical development.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 Information Systems Expertise
  • Understand business strategies, processes and technology as it relates to clinical development
  • Serve as domain expert to ensure data, process and/or technology interfaces are optimized across other clinical information systems that are integrated with these systems
  • Support internal audits and external inspections and assist with inspection preparation
Project Management
  • Define, lead and execute implementation plans to deliver on technology strategies and improvements
  • Develop critical success factors for pilots/projects and monitor progress to ensure clear criteria exists to enable decision making
  • Identify, monitor and communicate global customer (internal and external) needs/requirements related to process and/or technology performance and improvements
  • Lead organizational change, communication planning and training initiatives
  • Provide guidance and consulting for inspection readiness
  • Identify project implementation and system execution risks and raise issues appropriately
  • Lead progress reporting activities and system metrics to leadership, process owners and end users
Partnership
  • Partner with process owners, leadership, Quality and Information Technology to ensure capable, integrated and efficient system usage across the portfolio
  • Actively participate in shared learning across the team
  • Work with vendors to improve customer experience and efficiencies
Minimum Qualification Requirements:
  • Bachelor’s degree in a scientific or health related field
  • Minimum 3 years’ experience in medical, quality, clinical drug development, clinical information flow, quality and inspections
  • Deep knowledge of data collection and aggregation systems (prefer experience with Veeva EDC and CDB)
  • 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
Other Information/Additional Preferences:
  • Experience in clinical development systems as well as current and evolving technologies to support clinical development
  • Deep knowledge of cyber security, privacy, and or information security
  • Strong understanding of labs, including data flow and data management
  • Knowledge and/or experience in project management and organizational change with Lilly staff and external parties including vendors, industry experts and related organizations
  • Good interpersonal and leadership skills
  • Excellent oral and written communication skills
  • Strong business insight
  • Demonstrated strength in logical thought, problem solving ability and critical thinking
  • Ability to communicate and influence across functional boundaries
  • Ability and experience in positively handling and resolving conflict
  • Flexibility in approach; able to adjust to unexpected business opportunities while also being a catalyst for change
  • Knowledge of regulatory and quality requirements governing clinical development
  • Indianapolis based
  • 10% or less travel
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. 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 - $162,800Full-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

Eli Lilly