Associate Director, Clinical Operations — Trials Leader

BioSpace; Indianapolis (IN); On-site; USD 117,000 - 189,000; Full time

Benefits offered by this job

Bonus eligibility

401(k) plan

Pension

Vacation benefits

Health, dental, vision coverage

Job summary

Lilly, headquartered in Indianapolis, invites a seasoned Associate Director, Clinical Operations, to lead end-to-end trial activities across Orexin programs. You will drive operational plans, budgets, and cross-functional collaboration to meet study objectives in a compliant, timely manner.

The role requires 8+ years in pharma/biotech/CRO settings, strong leadership, and experience with global Phase 1–3 studies and regulatory submissions.

Qualifications

• Bachelor’s degree in sciences; advanced degree preferred.
• 8+ years in pharmaceutical/biotech/CRO environments.
• Experience managing multi-phase trials (Phase 1–3) globally.

Responsibilities

• Lead end-to-end clinical trial operations from start-up to close-out.
• Develop operational plans, timelines, and performance metrics.
• Collaborate with Regulatory, Data Management, Biostatistics, Safety, and other teams.
• Oversee budgets and ensure studies stay within financial parameters.
• Provide updates on study status, risks, and milestones to leadership.
• Ensure compliance with GCP, ICH, and SOPs; support inspections.
• Manage CROs, vendors, and external partners.

Skills

Trial management leadership

Cross-functional collaboration

GCP/ICH knowledge

Regulatory submissions support

Vendor management

Communication skills

Organizational skills

Proactive problem-solving

PMP certification

Education

Bachelor's degree in sciences

Advanced degree preferred

Tools

Clinical Trial Management Systems

Job description

Lilly, headquartered in Indianapolis, invites a seasoned Associate Director, Clinical Operations, to lead end-to-end trial activities across Orexin programs. You will drive operational plans, budgets, and cross-functional collaboration to meet study objectives in a compliant, timely manner.

The role requires 8+ years in pharma/biotech/CRO settings, strong leadership, and experience with global Phase 1–3 studies and regulatory submissions.