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.

Organization Overview:

Clinical Results Systems delivers innovative and reliable systems, processes, and information to enable clinical development and speed medicines to patients. The Associate Director – Results Reporting Systems role requires broad expertise of the systems used in the data collection process area, specifically relating to results reporting systems used by Statistics, Data & Analytics (SDnA). This requires an in-depth understanding of standards from CRF to TFLs, as well as the supporting processes and technology.

Working closely across geographies with colleagues in SDnA, LRL, CDDA, Tech@Lilly, and other components of the R&D organization, the Associate Director – Results Reporting Systems is responsible for managing and supporting multiple complex projects and technologies and ensures the on-time delivery of solutions that are aligned to business processes. The Associate Director ensures quality practices are in place around systems and maintains a strong understanding of the supporting business processes and application support requirements and provides influence at multiple levels within the business and by partnering with Quality and Tech@Lilly where appropriate.

Responsibilities:

Coordinate and lead the support of existing technology and tools

Understand business processes and support needs across all departments within SDnA.

Partner with Tech@Lilly to assist with the implementation of Clinical Results Systems technology needs.

Develop and maintain a global power user network for the supported applications.

Assist with the development and maintain metrics to evaluate the effectiveness of support delivery.

Partner with vendors and Tech@Lilly to enable appropriate technology for external business partners.

Assist with the management of existing vendor relationships for systems support.

Partner with Tech@Lilly and Quality to develop appropriate validation documents for software and tools.

Identify and resolves quality issues related to system, tools, and technology.

Support internal audits and external inspections

Proactively optimize support delivery.

Partner with Clinical Results Systems management, business domain experts and other functions to implement and support new technology to meet business needs

Define, lead and implement plans to deliver on technology strategies and improvements

Develop critical success factors for pilots/projects 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

Have an awareness of the modernization efforts within Clinical Results Systems and SDnA organizations.

Appropriately challenge and influence cross-functionally.

Effectively translate technical problems and solutions to a non-technical audience.

Ensure proper business requirements have been defined for all Tech@Lilly related projects by partnering with appropriate departments within Clinical Results Systems and SDnA

Ensure systems are meeting defined business requirements through coordinated testing and monitoring efforts.

Assist with the determination of priorities of projects in collaboration with Clinical Results Systems management when competing for limited resources.

Work closely with Tech@Lilly to ensure alignment of end user tools with overall Tech@Lilly strategy.

Basic Requirements:

Bachelor’s degree

Five or more years of experience in clinical drug development from data collection through analysis/integrated databases/submission work or experienced in data driven information systems.

Additional Skills/Preferences:

Experience in leading multiple sophisticated projects and/or teams to achieve superior business results.

Demonstrated ability to provide effective account management with internal business partners

Demonstrated leadership; ability to achieve results through others and influence across functions

Strong problem-solving skills; able to recognize problems before they become serious and take corrective action

Excellent self-management and organizational skills are essential; able to manage workload and adjust personal priorities, as needed based on guidance from supervision

Excellent oral and written communication skills; able to communicate clearly and succinctly up and down the organization

Demonstrated negotiation skills; applies experience and knowledge to persuade others to reach sound decisions

Flexibility to adjust quickly and effectively to frequent change and altered priorities

In depth knowledge of Statistical Sciences, CDISC Standards, and/or Data Management with respect to clinical trial data collection, analysis and reporting activities

Effective teamwork skills; able to adapt to diverse interpersonal styles

Sound understanding of integrating and managing big data and coding in statistical based tools like SAS and/or R

Experience validating systems and software under regulatory requirements around ICH, GCP, Pharm, etc.

Experience in leading all aspects of process changes

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

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.

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