Associate Director Clinical Delivery Capabilities - EMP

About the role

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.

Responsibilities

• Establish networks with other key support areas to efficiently and effectively support exploratory and biopharmaceutics clinical studies.
• Own updates to corporate systems and processes such as CT Registry, Vault Clinical; trial and compound level documentation management such as eTMF and the contracting elements for a study.
• Lead and partner in the issue customer concern and relationship management processes, vendor and clinical research unit assessments as appropriate.
• Maintain awareness of regulatory issues and trends relevant to assigned portfolio.
• Provide leadership in business processes supporting early phase development.
• Establish expertise on key business systems that support exploratory and biopharmaceutics clinical development.
• Review 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.
• Drive definition of metrics or measures to quantify exploratory and biopharmaceutics clinical development portfolio results and assess process effectiveness.
• Develop a metrics / measures and evaluation strategy for the organization. Establish and operationalize the processes to support this strategy e.g. scorecard generation.
• Drive identification and development of emerging technologies to support the advancement of medicines to the clinic. e.g. Artificial Intelligence tools.
• 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, Clinical Information and Process Automation, 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.

Qualifications

• Bachelor’s degree in a science related field from an accredited college or university; or equivalent qualifications/experience (3-years’ experience in the pharmaceutical industry with direct experience of managing clinical studies).
• Project management and time management skills.
• Experience working cross-culturally and in a virtual work environment.
• Ability to travel (up to 10% expected – varies dependent on responsibilities).