Associate Director​/Director, Clinical Delivery Capabilities - EMP

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We’re looking for people who are determined to make life better for people around the world.

The purpose of the Associate Director/Director Clinical Delivery Capabilities role within Exploratory Medicine and Pharmacology 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 continually provides expertise in process and methodologies of 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 business acumen, 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 continuous improvement opportunities.

• Establish networks with other key support areas to efficiently and effectively support exploratory and biopharmaceutics clinical studies. The team will support study development by owning updates to corporate systems and processes e.g. CT Registry, Vault Clinical, trial and compound level documentation management e.g. eTMF and the contracting elements for a study.
• Provide leadership in business interactions with TPO partners; helping to execute the exploratory and biopharmaceutics clinical development portfolio. Lead and partner in the issue escalation 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.
• Established 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.
• Draw on deep exploratory and biopharmaceutics clinical development knowledge and process expertise to review processes and when necessary, 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 utilized 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.

• Drive definition of metrics or measures to quantify exploratory and biopharmaceutics clinical development portfolio deliverables and assess process effectiveness.
• Develop a metrics / measures and evaluation strategy for the organization. Establish and operationalize the…