Senior Associate / Manager, Clinical Development Trial Lead (CDTL)

Purpose The Clinical Development Trial Lead (CDTL) Associate leads the cross‑functional study team in the development and execution of clinical trials and is accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget. The CDTL Associate leverages project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial deliverables. Trial Leadership and Regional Operational Knowledge Develop and track global milestones by gaining alignment and integrating inputs across functions and geographies. Assess, identify and monitor trial‑level risks. Incorporate scientific knowledge, trial process, and regional expertise to create an integrated risk mitigation and contingency plan. Understand cross‑functional trial‑level budget components. Create and monitor grants and non‑grants, and assumptions using financial tracking tools. Routinely network with appropriate business partners on trial‑level budget status and changes. Regional Collaboration and Operations Partner with other organizations to 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 teams throughout study implementation, execution, and closure, empowering them to meet clinical trial deliverables, including issue management, contingency planning and issue resolution. Be accountable for trial/regional enrollment strategy and execution 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 organizations (TPOs). Apply problem‑solving skills to daily issues with the cross‑functional study team (including 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, regulation and new technology. Manage TPO qualification process, selection and oversight. Demonstrate understanding of the drug development process and acknowledge the inter‑relatedness of cross‑functional activities to 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 obtaining regional input to provide to the study teams. Serve as the 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 the 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 the 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 their questions, 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. Minimum Qualification Requirements Bachelor’s or university degree (scientific or health‑related field preferred). Three years of clinical research experience or relevant clinical trial experience in a scientific or health‑related field; or an advanced degree. 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. Highly Desired Skills 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 manage complex situations through problem‑solving, critical thinking and navigating ambiguity. Flexibility to adjust to altered priorities. Other Information / Additional Preferences Need to travel periodically to AST/ISST/Investigator Engagement meetings and potentially other scientific or regional symposiums. 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. Compensation and Benefits Actual compensation will depend on a candidate’s education, experience, skills and geographic location. The anticipated wage for this position is $65,250 – $148,500. Full‑time equivalent employees are also eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k), pension, vacation benefits, medical, dental, vision and prescription drug benefits, flexible benefits such as 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 such as employee assistance program, fitness benefits and employee clubs and activities. Lilly reserves the right to amend, modify or terminate its compensation and benefit programs at its discretion, and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #J-18808-Ljbffr Initial Therapeutics, Inc.