Global Head of Phase 1 Clinical Operations

Metaphore Biotechnologies; Somerville (NJ); On-site; USD 213,000 - 280,000; Full time

Benefits offered by this job

Healthcare coverage

Annual incentive program

Retirement benefits

Other benefits

Job summary

Metaphore Biotechnologies, Inc. seeks a Senior Director of Clinical Operations to lead hands-on execution of early clinical development activities for the company's first-in-human program.

Reporting to the Chief Medical Officer, this senior IC role owns operational planning across CROs, vendors, sites, and regulatory coordination with urgency and rigor. The candidate will drive Phase 1 readiness, global start-up, and milestones, working across internal teams, external partners, and consultants

Qualifications

• BS/MS/PhD in a scientific/healthcare or related field; an advanced degree is preferred.
• 10+ years of progressive clinical operations experience in biotech or pharma.
• Direct experience leading first-in-human or Phase 1 studies from planning to execution.
• Strong knowledge of CRO/vendor selection, site strategy, and start-up.
• Experience managing study budgets, contracts, timelines and forecasts.
• Experience reviewing protocols and translating designs into operational plans.
• Experience with early-phase studies in DMPK/biomarker contexts is a plus.
• Broad understanding of FDA/EU ex-U.S. trial requirements; ICH-GCP knowledge.

Responsibilities

• Lead clinical operations planning and execution for early development programs with FM1 readiness.
• Develop integrated study plans, timelines, budgets, and risk-mitigation strategies.
• Oversee CRO/vendor selection, MOUs, budget negotiations, and change orders.
• Partner with Clinical Development and Medical leadership on protocols and feasibility.
• Represent Clinical Operations on cross-functional teams and external partners.
• Establish Phase 1 site strategy and manage global start-up requirements.
• Ensure compliance with ICH-GCP and regulatory quality standards.
• Maintain TMF completeness and inspection readiness.
• Identify and mitigate operational risks across sites, vendors, and data delivery.

Skills

Clinical operations leadership

First-in-human study planning

Vendor management

CRO oversight

Regulatory coordination

Ish-GCP knowledge

Program/study budgeting

Cross-functional collaboration

Site activation

Education

BS/MS/PhD in scientific/healthcare field

Advanced degree preferred

Job description

Metaphore Biotechnologies, Inc. seeks a Senior Director of Clinical Operations to lead hands-on execution of early clinical development activities for the company's first-in-human program.

Reporting to the Chief Medical Officer, this senior IC role owns operational planning across CROs, vendors, sites, and regulatory coordination with urgency and rigor. The candidate will drive Phase 1 readiness, global start-up, and milestones, working across internal teams, external partners, and consultants