Sr Director Cdos Process Owner - Clinical Trial Foundations

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Sr Director/Executive Director, CDOS Process Owner

Clinical Trial Foundations

Purpose:

Clinical Trial Foundations as part of Clinical Design, Delivery & Analytics (CDDA) provides leadership in the strategy and development of contemporary clinical trial processes, technologies, information and capabilities and in shaping external policy and guidance to speed the delivery of medicines to patients globally. The CDOS Process Owner is accountable to speed innovation by providing clinical development expertise, focused ownership and effective management of their assigned global processes, such that they are compliant, fit-for-purpose, and efficient. The CDOS Process Owner is responsible for the end-to-end process design, management and continuous improvement across functional lines. To achieve this, the CDOS Process Owner will work closely with CDDA leadership, and partner with functional leaders across LRL, the Business Units, supporting areas (e.g., Medical Quality, Ethics and Compliance, Legal, HR and IDS), and third party clinical development partners to lead efforts to design, sustain and continuously improve the efficiency and effectiveness of their assigned global 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

• Leverages drug development expertise, and knowledge of internal and external requirements, industry best practices and benchmarks, inspection and audit findings, new capabilities, and advances in technology including information flow to define operational strategy and design processes that meet overall clinical development performance objectives.
• Maintains an integrated holistic view across CDOS processes ensuring cohesion and alignment.
• Establishes deep knowledge and 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.
• Drives opportunities to automate and streamline processes as new systems and technologies are adopted.
• Leads cross-functional project teams through development of process maps, process documentation (e.g. quality system documents, etc), and personnel qualification strategies.
• Establishes qualification requirements for those individuals within functions and teams who will execute processes.
• Establishes process controls (i.e., key measures for risk, quality defects, speed and cost) by which each process will be assessed.
• Defines and manages the continuous improvement agenda for the end-to-end processes and ensures compliance within a continually changing regulatory and industry landscape.
• Communicates to governance bodies on process performance and any remediation/change efforts.
• 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.
• Partner with CDOS team members, 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.
• Support inspection readiness with teams, partner with quality and functional leaders on responses to audit and inspection findings.

Expertise and Employee Development

• Engage in coaching and training, as needed, to ensure the effective implementation and execution of the processes they own.
• Effectively engage in the external environment to ensure a continuous state of awareness regarding current and evolving trends in relevant topic areas. Effectively incorporate learnings into training and development and process improvement initiatives. Influence industry through participation in cross-industry initiatives and by providing feedback on draft guidance.
• Some Sr Directors may have direct reports, depending on the scope and nature of their assigned processes. For those who have direct reports, the following responsibilities are applicable.
• Set expectations for employees within their team with regard to process management, measurement and continuous improvement, as well as influence and partnership with relevant functions.
• Continually strengthen and improve the capability and expertise of their staff to drive simplification and continuous improvement throughout Lilly's clinical drug development systems and business processes.
• Recruit and maintain an effective team with diverse backgrounds and skill sets. Ensure their development through experiences, the application of HR processes, and support of technical knowledge development.

Project Leadership Related to Area of Process/System Ownership

• Identify and lead complex, large-scale, cross-functional projects that are within or synergistic with their scope of process ownership and critical to the business.
• Authoritatively represent assigned processes within broader change or transformation initiatives.
• System ownership as assigned/needed for systems supporting their processes

Minimum Qualification Requirements:

• Bachelor's Degree, preferably in a science- or health-related field.
• A minimum of 8 years experience in clinical drug development.

Other Information/Additional Preferences:

• Advanced degree (Masters, Doctorate) in a science-related field.
• Demonstrated influence with peers, management and senior leadership
• Demonstrated ability to anticipate future state and drive and lead cross-functional changes proactively.
• Proven ability to synthesize information from multiple sources, distill information and drive toward risk-based and simplified recommendations
• Experienced in multiple facets of drug development and/or pharma project management experience.
• A deep understanding of quality systems and process management and external regulatory/policy environment as applicable to their areas of focus
• Understanding of IT systems, connectivity across systems and data flow
• 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.
• Demonstrated ability to recruit and develop top talent.
• Demonstrated effective communication skills.
• Located in Indianapolis.
• Some travel required.

If you are using a printed copy of this document, make sure it is the most current approved version.

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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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$156,000 - $228,800

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.

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