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:
Clinical Trial Foundations (CTF) delivers innovative and reliable supplies, systems, processes, and information to enable clinical development and speed medicines to patients. The Associate Director/Director, CTF Clinical Development Operating System Process Management is responsible to design, sustain and improve the efficiency and effectiveness of their assigned global processes. The role applies their technical and process management expertise to effectively manage their assigned processes, and to ensure they are compliant, fit-for-purpose, and efficient. To achieve this, the – role is expected to collaborate across involved functional leaders and subject matter experts, Quality, and Learning and Development (L&D) in an effort to improve the efficiency and effectiveness of their assigned processes.

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.

• Business Process Ownership
  

 Establishes clear understanding of assigned processes including clarity of process inputs, outputs and dependencies (e.g., connected processes, data standards, information flow implications, etc.), and role accountability for critical steps and decisions.
 Leads project teams through development of process maps, process documentation (e.g.,quality system documents, etc), and personnel qualification strategies. Approves -quality system documents and L&D training associated with process change
 Partners with Process Owners to ensure processes integrate with the end-to-end clinical development process in order to deliver efficiencies needed to deliver on clinical research.
 Proposes qualification requirements to Process Owners for those individuals within functions and teams who will execute processes.
 Defines and evaluates metrics to monitor performance of processes making recommendations for improvement.
 Understands the external environment and changes that may affect their assigned processes and leads the development of action plans, as needed.
 Influence key stakeholders concerning the design, timing and implementation of process changes to ensure changes are well integrated into the overall operating system and uptake by the business is optimized.
 Collaborates with other Process Owners, functional leaders, subject matter experts (SMEs), Quality, Compliance and Legal to define applicable compliance and business requirements to design efficient and compliant processes.
 Partners with Process Owners across multiple teams, line management and subject matter experts (SMEs) to ensure process execution expectations are clear, collect process performance feedback, and make sure the process runs smoothly and efficiently.
 Engage in coaching and training others, as needed, to ensure the effective implementation and execution of assigned processes.

• Project Leadership Related to Area of Process Ownership
  

 Define and lead projects that are within their scope of process ownership.
 Authoritatively represent assigned processes within broader change initiatives.

Minimum Qualification Requirements:

 Bachelor’s Degree, preferably in a science- or health-related field.
 A minimum of five years experience in drug development.

Other Information/Additional Preferences:

 Demonstrated influence with peers and management.
 Demonstrated ability to lead change for focus area(s).
 Proven ability to synthesize information from multiple sources and make risk-based decisions.
 Experienced in drug development and/or pharma project management experience.
 Understands quality systems and process management.
 Six Sigma Black Belt or Green Belt experience.
 Demonstrated ability to collaborate across boundaries and achieve results with internal and external partners.
 Ability to work in a dynamic environment and deal with complexity.
 Located in Indianapolis.

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 an EEO/Affirmative Action Employer and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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