Senior Clinical Ops Lead - Trials (Remote)

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company

Boston (MA)

Remote

USD 103,000 - 152,000

Full time

11 days ago
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Benefits offered by this job

401(k)
Wellness programs
Other discounts

Job summary

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, seeks an Associate Director, Clinical Operations (Contract) to provide leadership across the clinical development lifecycle. The role oversees trials, manages budgets, and ensures compliance with GCP/ICH while coordinating with multiple functions.

The position is remote in the US with occasional travel and potential conversion to permanent. Requires 8+ years in clinical operations and strong cross-functional leadership.

Qualifications

  • Bachelor’s degree in sciences field required; advanced degree preferred.
  • 8+ years of experience in pharmaceutical, biotechnology, or CRO environments.
  • Proven experience managing clinical trials across multiple phases (Phase 1–3), including domestic and international studies.
  • Experience supporting global clinical trials preferred.
  • CNS and/or sleep disorder experience preferred.
  • PMP certification or formal project management training is a plus.
  • Demonstrated leadership and ability to influence cross‑functional teams without direct authority.

Responsibilities

  • Lead and oversee end-to-end clinical trial operations from study start-up through close-out for Orexin programs.
  • Develop and execute operational plans, timelines, and performance metrics.
  • Partner with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Safety, and other functions.
  • Develop, manage, and track study budgets within approved financial parameters.
  • Provide updates on study status, risks, and milestones to senior leadership.
  • Identify operational risks and implement mitigation strategies.
  • Support execution of contracts, clinical trial agreements, and study budgets.
  • Contribute to regulatory strategy and support FDA submissions.
  • Manage CROs and external partners to ensure high-quality performance.
  • Ensure compliance with SOPs, GCP, and ICH; support inspection readiness.

Skills

Clinical trial operations
GCP & ICH knowledge
Cross-functional leadership
Regulatory submissions support
Vendor/CRO management
Budget management
Project management
Communication & collaboration

Education

Bachelor’s degree in sciences
Advanced degree preferred

Tools

Clinical trial management systems

Job description

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, seeks an Associate Director, Clinical Operations (Contract) to provide leadership across the clinical development lifecycle. The role oversees trials, manages budgets, and ensures compliance with GCP/ICH while coordinating with multiple functions.

The position is remote in the US with occasional travel and potential conversion to permanent. Requires 8+ years in clinical operations and strong cross-functional leadership.

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