Associate Director, Clinical Development Trial Lead (CDTL)

Benefits

Additional Information

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Summary : The Associate Director, Clinical Development Trial Lead (CDTL) independently leads the cross-functional study team in the development and execution of complex clinical trials and is accountable both regionally and globally to deliver clinical milestones on trial(s) with quality, on time, and within scope and budget. The Associate Director, CDTL consistently demonstrates independent leadership, influence when working with study teams, management, and business partners, and prospective identification of issues and resolution thereof. Project Management, and Regional Operational Knowledge Broader responsibilities at Therapeutic Area/ Molecule/Indication level (e.g. attending relative critical chain network builds, providing input on strategy). Use project management skills, processes, and tools to develop and execute local, regional, and/or global clinical trials (CT) as described: Scope - Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make adjustments and changes (per change control process) as needed to meet the deliverables of the trial. Timeline - Develop and track global trial enrollment plan by gaining alignment and integrating inputs across functions and geographies. Provide consultation and guidance to CDTLs on their integrated plans. Risk - Assess, identify and monitor trial-level risks. Budget - Understand the cross-functional, trial-level budget components. Create and monitor the budget grants and non-grants, and assumptions using financial tracking tools. Routinely network with appropriate business partners on trial-level budget status and changes. Function as point of contact for other CDTLs on their clinical team as needed regarding budget items. Lead, influence and project manage large, complex studies and/or multiple smaller studies. Partner with other organizations to coordinate and actively participate in Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs). Independently drive and influence local, regional and global, cross-functional study team throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including proactive issue management, contingency planning and issue resolution. Drive to solutions across the molecule/program. Be accountable for trial/regional/program/molecule enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET) Partner with the Regional Operations to achieve regional enrollment goals. Anticipate and resolve complex and key technical operational or business problems with cross-functional study team (including vendors, affiliates/regions, global team members, and other business partners) with little to no need for direct management support. Evaluate and identify issues that require escalation. Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc. Use expertise to make timely decisions for ambiguous and complex situations. Manage TPO (third party organization) qualification process, selection, and oversight. Serve as the CRO (Clinical Research Organization) clinical development point of contact for outsourced and fully outsourced trial execution. Ensure CRO delivery of project milestones. Clinical Trial Process Leadership and Expertise Leverage and demonstrate broad understanding of therapeutic, clinical drug development, and process expertise in order to influence study design and program-level decisions considering regional needs. Recognize 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 across functional teams, regions, and external partners and make decisions on process and issues affecting study implementation and execution. Be knowledgeable on the global and regional operating model; coordinate and facilitate obtaining regional input to provide to the study teams. Single point of accountability for the Trial Master File for assigned trials, working closely with functional record owners to ensure the file is current and inspection ready at all times. Ensure inspection readiness of respective clinical trial(s). Ensures timely documentation of deviations, creation of story boards or