Associate Director - Clinical Operations

Verve Therapeutics Clinical Study Manager

At Lilly, we unite caring with discovery to make life better for people around the world. Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company within Lilly Research Labs, is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. The company's initial three programs target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease.

Responsibilities :

• Drive and oversee all aspects of clinical studies from planning to close-out, ensuring adherence to timelines, budgets, and regulatory guidelines.
• Develop and implement operational plans for clinical studies, managing CROs and vendors to ensure high-quality execution.
• Lead internal clinical trial team meetings, tracking key study metrics to ensure progress and alignment with company goals.
• Partner with cross-functional teams to support the strategic development and execution of clinical programs.
• Partner with cross-functional team and CRO to ensure patient recruitment and retention strategies are carried out effectively.
• Ensure efficient database lock by overseeing monitoring plans and taking part in data review and reconciliation efforts.
• Contribute to the development and review of key regulatory documents.
• Assist in maintaining a quality-focused clinical infrastructure by developing, revising, and implementing SOPs.
• Engage in the planning of quality assurance activities and coordinate remediation of audit findings.
• Lead vendor selection, contract / budget negotiation, and management.
• Develop and maintain project budget forecasts.
• Provide ongoing oversight, maintenance and evaluate completeness of the Trial Master File.
• Lead, mentor, and develop a high-performing team.
• Set clear objectives, delegate responsibilities, and drive strategic alignment with company priorities.
• Cultivate an inclusive and collaborative culture.
• Make data-driven decisions, providing insightful recommendations.
• Build strong relationships with senior management and external partners.
• Partner with internal teams and external partners to ensure seamless execution of clinical studies.

Basic Qualifications / Requirements :

Additional Skills / Preferences :

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