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.

About the Role

The Clinical Trial Foundations team, part of Clinical Design, Delivery & Analytics (CDDA), provides leadership in the strategy and development of contemporary clinical trial processes, technologies, information, and capabilities. It also shapes external policy and guidance to speed the delivery of medicines to patients globally. The CDOS Process Owner is accountable for accelerating innovation by providing clinical development expertise, focused ownership, and effective management of assigned global processes to ensure they are compliant, fit-for-purpose, and efficient. This role is responsible for end-to-end process design, management, and continuous improvement across functional lines.

The CDOS Process Owner will collaborate closely with CDDA leadership and partner with functional leaders across LRL, Business Units, supporting areas (e.g., Medical Quality, Ethics and Compliance, Legal, HR, and IDS), and third-party clinical development partners to design, sustain, and continuously improve the efficiency and effectiveness of assigned global processes.

Responsibilities

• Business Process Ownership
  • Leverage drug development expertise, internal and external requirements, industry best practices, benchmarks, inspection and audit findings, and advances in technology to define operational strategy and design processes that meet clinical development performance objectives.
  • Maintain an integrated, holistic view across CDOS processes to ensure cohesion and alignment.
  • Develop deep knowledge of assigned processes, including clarity of inputs, outputs, dependencies (e.g., connected processes, data standards, information flow), and role accountability for critical steps and decisions.
  • Drive automation and streamlining of processes as new systems and technologies are adopted.
  • Lead cross-functional project teams in developing process maps, documentation (e.g., quality system documents), and personnel qualification strategies.
  • Establish qualification requirements for individuals executing processes within functions and teams.
  • Define process controls (e.g., key measures for risk, quality defects, speed, and cost) to assess process performance.
  • Manage the continuous improvement agenda for end-to-end processes and ensure compliance within a dynamic regulatory and industry landscape.
  • Communicate process performance and remediation/change efforts to governance bodies.
  • Collaborate with other Process Owners, functional leaders, subject matter experts (SMEs), Quality, Compliance, and Legal to design efficient and compliant processes.
  • Partner with CDOS team members, line management, and SMEs to clarify process execution expectations, collect performance feedback, and ensure smooth and efficient process operation.
  • Support inspection readiness and partner with Quality and functional leaders on responses to audit and inspection findings.
• Expertise and Employee Development
  • Engage in coaching and training to ensure effective implementation and execution of owned processes.
  • Maintain awareness of current and evolving trends in relevant topic areas and incorporate learnings into training, development, and process improvement initiatives.
  • Influence the industry through participation in cross-industry initiatives and by providing feedback on draft guidance.
  • For roles with direct reports:
    • Set expectations for employees regarding process management, measurement, continuous improvement, and cross-functional influence and partnership.
    • Strengthen and improve team capabilities to drive simplification and continuous improvement in Lilly’s clinical drug development systems and business processes.
    • Recruit and maintain an effective team with diverse backgrounds and skill sets, ensuring development through experiences, HR processes, and technical knowledge support.
• Project Leadership
  • Identify and lead complex, large-scale, cross-functional projects within or synergistic with the scope of process ownership that are critical to the business.
  • Authoritatively represent assigned processes within broader change or transformation initiatives.
  • Assume system ownership for systems supporting assigned processes, as needed.

Requirements

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

Qualifications

• Advanced degree (Masters, Doctorate) in a science-related field.
• Demonstrated influence with peers, management, and senior leadership.
• Proven ability to anticipate future state and proactively drive and lead cross-functional changes.
• Ability to synthesize information from multiple sources, distill insights, and drive risk-based, simplified recommendations.
• Experience in multiple facets of drug development and/or pharma project management.
• Deep understanding of quality systems, process management, and the external regulatory/policy environment relevant to 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 manage complexity.
• Demonstrated ability to recruit and develop top talent.
• Strong communication skills.
• Based in Indianapolis with some travel required.

Pay

The anticipated wage for this position is $156,000 - $228,800. Full-time equivalent employees are also eligible for a company bonus (depending on company and individual performance).

Benefits

• Comprehensive benefit program, including eligibility to participate in a company-sponsored 401(k) and pension plan.
• Vacation benefits.
• 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.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).