Sr Director CDOS Process Owner - Clinical Trial Foundations

About the Role

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

• 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.
  • Partners 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.
  • Supports inspection readiness with teams, partners with quality and functional leaders on responses to audit and inspection findings.
• Expertise and Employee Development
  • Engages in coaching and training, as needed, to ensure the effective implementation and execution of the processes they own.
  • Effectively engages in the external environment to ensure a continuous state of awareness regarding current and evolving trends in relevant topic areas.
  • Effectively incorporates learnings into training and development and process improvement initiatives.
  • Influences 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:
    • Sets 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 strengthens and improves the capability and expertise of their staff to drive simplification and continuous improvement throughout Lilly's clinical drug development systems and business processes.
    • Recruits and maintains an effective team with diverse backgrounds and skill sets. Ensures their development through experiences, the application of HR processes, and support of technical knowledge development.
• Project Leadership Related to Area of Process/System Ownership
  • Identifies and leads complex, large-scale, cross-functional projects that are within or synergistic with their scope of process ownership and critical to the business.
  • Authoritatively represents assigned processes within broader change or transformation initiatives.
  • System ownership as assigned/needed for systems supporting their processes.

Minimum Qualifications

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

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.

Benefits

• Eligibility for a company bonus (depending, in part, on company and individual performance).
• Comprehensive benefit program 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).

Pay

The anticipated wage for this position is $156,000 - $228,800. Full-time equivalent employees also will be eligible for a company bonus.