Senior Director, Clinical Operations — Phase 1 Global Lead

Metaphore Biotechnologies; Somerville (MA); In loco; USD 213.000 - 280.000; Tempo pieno

Vantaggi offerti da questo lavoro

Healthcare coverage

Annual incentive program

Retirement benefits

Other benefits

Descrizione del lavoro

Metaphore Biotechnologies, Inc. is seeking a Senior Director of Clinical Operations to lead hands-on execution of early clinical development for the company’s first-in-human program. Reporting to the CMO, this is a senior individual-contributor role with broad ownership.

You will own clinical operations planning and study execution, including CRO/vendor oversight, site strategy, regulatory coordination, and global start-up, with focus on Phase 1 readiness and cross-functional collaboration.

Competenze

• 10+ years of progressive clinical operations experience in biotech/pharma.
• Direct experience leading first-in-human or Phase 1 studies.
• Strong CRO/vendor selection, budgeting, and timelines management.
• Experience translating study designs into executable operational plans.
• Knowledge of FDA, EU, ICH-GCP requirements and TMF standards.

Mansioni

• Lead clinical operations planning and execution for early development programs, with primary accountability for first-in-human readiness and global start-up.
• Develop integrated study plans, timelines, budgets, forecasts, and risk mitigation strategies.
• Oversee CRO/vendor selection, scope of work, budgets, and performance monitoring.
• Partner with Clinical Development and Medical leadership on protocols and feasibility.
• Represent Clinical Operations on cross-functional study teams and coordinate global start-up.

Conoscenze

Clinical operations

Vendor management

Budget management

ICH-GCP

Cross-functional collaboration

Study start-up planning

Formazione

BS/MS/PhD in science/healthcare

Descrizione del lavoro

Metaphore Biotechnologies, Inc. is seeking a Senior Director of Clinical Operations to lead hands-on execution of early clinical development for the company’s first-in-human program. Reporting to the CMO, this is a senior individual-contributor role with broad ownership.

You will own clinical operations planning and study execution, including CRO/vendor oversight, site strategy, regulatory coordination, and global start-up, with focus on Phase 1 readiness and cross-functional collaboration.