Manager, Clinical Development Trial Lead (CDTL)

Basic Requirements

• Bachelor’s degree (scientific or health-related field preferred)
• 3+ years clinical research experience or relevant clinical trial experience in a scientific or health-related field
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1
• Candidate will be required to sit onsite at our Stamford, CT facility or our Corporate Center in Indianapolis, IN. Relocation assistance can be provided for qualified candidates.

• Experience with early phase oncology
• Experience with Radioligand Therapy (RLT)
• Applied knowledge of trial execution methodology, processes, and tools
• Demonstrated ability to work cross-culturally with global colleagues and with TPOs
• Ability to influence without authority
• Strong leadership and networking skills exhibited while working in cross-functional and cross-cultural teams (internal & external) and on projects
• Effective and influential communication, self-management, and organizational skills
• Demonstrated ability to handle complex situations through problem-solving, critical thinking and navigating ambiguity
• Flexibility to adjust to altered priorities
• Need to travel periodically to Investigator Engagement meetings and other scientific or regional symposiums

• Use processes and tools to develop, execute, and deliver local, regional and/or global clinical trials as described below:
• Scope - Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make changes as needed to meet the deliverables of the trial.
• Timeline – Develop and track global milestones by gaining alignment and integrating inputs across functions and geographies.
• Risk - Assess, identify and monitor trial-level risks. Incorporate scientific knowledge, trial process, and regional expertise to create one integrated trial-level risk mitigation and contingency plan.
• Budget - Understand the cross-functional, trial-level budget components. Create and monitor the grants and non-grants, and assumptions using tracking tools. Routinely network with business partners on trial-level budget status and changes.
• Partner with organizations to coordinate and deliver training and 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
• Partner with the Investigator Engagement organization to achieve regional enrollment goals.
• Handle 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 meaningful trends such as industry, regulatory, new technology, etc.
• Handle TPO qualification process, selection, and oversight.

• 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.
• Be knowledgeable of the global and regional operating model; coordinate and facilitate acquiring 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 apply 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.
• Demonstrate ability to 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.

• Use 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.
• Use clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business and clinical programs.