Clinical Development Trial Lead (CDTL)

Primary Responsibilities

• Use processes and tools to develop, execute, and deliver local, regional and/or global clinical trials as described below.
• Understand the scope of work required to complete the clinical trial successfully.
• Maintain and update global milestones by gaining alignment and integrating inputs across functions and geographies.
• Assess, identify, and monitor trial-level risks, incorporating scientific knowledge, trial process, and regional expertise to create one integrated trial-level risk mitigation and contingency plan.
• Understand and manage the cross-functional, trial-level budget components, creating and monitoring the grants and non-grants, and assumptions using financial tracking tools.
• Coordinate and deliver Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs)/Investigator Engagement Meetings.
• Drive and coordinate local, regional and global, cross-functional study team throughout study implementation, execution and closure, empowering them to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution.
• Be accountable for trial/regional enrollment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET).
• Partner with the Investigator Engagement organization to achieve regional enrollment goals.
• Manage relationships and serve as a single point of contact and central owner for trial communication, to and from the Clinical Design and Delivery organization, all cross functional team members, and Third Party Organization (TPOs).
• Apply problem-solving skills to daily issues with cross-functional study team (including with vendors, affiliates/regions, global team members and other business partners).
• Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.
• Manage TPO qualification process, selection, and oversight.

Clinical Trial Process Leadership and Expertise

• Demonstrate understanding of drug development process.
• Acknowledge inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial.
• Look for opportunities to expand and deepen clinical trial process expertise.
• Coordinate and facilitate obtaining regional input to provide to the study teams.
• Single point of accountability for the Trial Master File, working closely with functional record owners to ensure the file is current and inspection ready at all times.
• Network and leverage expertise to anticipate trial and regional issues, identify areas of process breakdown, assess situations and propose proactive approaches that reduce and/or mitigate risks that impact ability to deliver the clinical trial.
• Lead and influence in the midst of ambiguity.
• Coach peers, cross-functional team members and TPOs on aspects of clinical trial process and regional specificities.
• Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation in the conduct of clinical trials.
• Liaise with affiliates and other appropriate resources to understand local regulatory requirements.

Scientific Expertise

• Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates.
• Combine scientific clinical trial operational knowledge, and process expertise to impact clinical trial design, feasibility implementation, and execution.
• Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business and clinical programs.