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. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines.

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.
• 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, ensuring efficient resource allocation, cost-effective execution, and punctual review of invoices.
• Provide ongoing oversight, maintenance and evaluate completeness of the Trial Master File.
• Lead, mentor, and develop a high-performing team by fostering collaboration, resolving challenges, and ensuring peak performance.
• Set clear objectives, delegate responsibilities, and drive strategic alignment with company priorities.
• Cultivate an inclusive and collaborative culture, empowering team members and reinforcing company values.
• Tackle complex challenges by integrating diverse perspectives into innovative, actionable strategies.
• Make data-driven decisions, providing insightful recommendations to shape project timelines, goals, and resource allocation.
• Build strong relationships with senior management and external partners, influencing key project outcomes and ensuring strategic alignment.
• Partner with internal teams and external partners to ensure seamless execution of clinical studies.

Basic Qualifications / Requirements :

Additional Skills / Preferences :

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Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $127,500 - $187,000. Full-time equivalent employees will also be eligible for a company bonus and a comprehensive benefit program.