Maintain awareness of regulatory issues and trends relevant to assigned portfolio.
Systems and Processe s Support:
Provide leadership in business processes supporting early phase development.
Established expertise on key business systems that support exploratory and biopharmaceutics clinical development.
R eview of established procedures across multiple subject areas, dependent on the change agendas to be evaluated and prioritized. Contribute to the overall strategic direction of cross-functional systems and process
Draw on deep exploratory and biopharmaceutics clinical development knowledge and process expertise to review processes and when vital, sponsor improvement initiatives to increase business efficiency and value.
Ensure cross-functional process alignment internally and externally where appropriate
Act as a key resource to internal governance committees regarding processes applied in the exploratory and biopharmaceutics clinical development
Ensure optimal network with the Quality , C linical I nformation and P rocess A utomation , and L&D organizations is established in order to guarantee processes deliver on Quality and Regulatory compliance requirements .
Lead organizational change initiatives to ensure successful adoption of new clinical delivery capabilities, systems, and processes.
Lead and collaborate with cross-functional teams to assess change impacts, develop communication strategies, and coordinate delivery of training.
Act as a change advocate, helping collaborators navigate transitions and embedding change into team culture and workflows
Systems, Metrics and Reporting :
Drive definition of metrics or measures to quantify exploratory and biopharmaceutics clinical development portfolio results and assess process effectiveness
Develop
Benefits
Health insurance
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.
Organization Overview:
The Associate Director/Director, Clinical Delivery Capabilities plays a critical role in shaping how Lilly selects, manages, and partners with external vendors to ensure the quality and on-time delivery of its early-phase medicine portfolio. This role will work cross functionally to set the operational standards, systems, and processes that hold clinical research partners accountable and drive consistent, high-quality outcomes across every study in the pipeline.
The purpose of the Associate Director/Director , Clinical Delivery Capabilities (CDC) role is to provide operational leadership to support exploratory and biopharmaceutics clinical development. The role works across the organization including with functional and organizational partner groups to deliver knowledge, expertise, standard templates, and technology to identify various clinical development scenarios and provide functional expertise to ensure successes of portfolio delivery . This role c ontinually provid es expertise in process and methodologies of Exploratory Medicine & Pharmacology (EMP) whilst looking for advancements and improvements. Key areas of responsibility of the role include: a) leading activities supporting study development and execution, b) cross-functional systems and processes, and c) systems, metrics and reporting. In addition to knowledge of ICH and quality guidelines needed for successful delivery of the portfolio and clinical trials, the Associate Director/Director possesses the discernment, process knowledge, and influence required to lead in process and quality improvement efforts. The Associate Director/Director will seek knowledge from internal and external sources and use this information to drive strategic discussions with clinical and functional counterparts make recommendations to gain efficiencies and speed to shape development plans and improvement opportunities.
Eli Lilly · Indianapolis IN