Global Phase 1 Clinical Operations Lead

Metaphore Biotechnologies, Inc.; Somerville (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Metaphore Biotechnologies, Inc. is seeking a Senior Director of Clinical Operations to lead hands-on early clinical development activities for its first-in-human program.

Reporting to the CMO, this senior individual-contributor role owns operational planning, site strategy, and cross-functional execution with CROs and vendors. The leader will manage global study start-up, regulatory coordination, and phase 1 readiness, partnering with internal teams and external partners to move studies forward

Qualifications

• BS/MS/PhD in a scientific, healthcare, or related discipline; an advanced degree is preferred.
• 10+ years of progressive clinical operations experience in biotechnology or pharma.
• Direct experience leading first-in-human or Phase 1 studies from planning through execution.
• Strong CRO/vendor selection and oversight, site strategy, global start-up, and planning.
• Experience managing study budgets, vendor contracts, and timelines.
• Experience translating study designs into operational plans.
• Experience with clinical pharmacology/DMPK related to early-phase designs.
• FDA/EU regulatory and ICH-GCP knowledge; sponsor oversight; TMF readiness.
• Ability to operate independently in a fast-paced, ambiguous environment.

Responsibilities

• Lead clinical operations planning and execution for early development programs and first-in-human readiness.
• Develop and maintain integrated study plans, timelines, budgets, forecasts, and risk mitigation.
• Lead CRO and vendor selection, RFPs, scope of work, budgets, and issue escalation.
• Collaborate with Clinical Development and Medical leadership on protocol feasibility and feasibility.
• Represent Clinical Operations on cross-functional teams with regulatory, safety, data, and QC partners.
• Develop and execute Phase 1 site strategy and activate sites with appropriate capabilities.
• Oversee global operational activities across multiple regions and start-up requirements.
• Ensure compliance with protocol, ICH-GCP, and internal quality standards.
• Maintain TMF and trial documentation readiness; monitor enrollment and risks.
• Establish scalable SOPs and governance for a growing biotechnology company.

Skills

Clinical operations leadership

Vendor management

Cross-functional collaboration

ICH-GCP knowledge

Global study start-up

Budget management

Protocol review

Communication

Travel willingness

Education

BS/MS/PhD in scientific/healthcare

Job description

Metaphore Biotechnologies, Inc. is seeking a Senior Director of Clinical Operations to lead hands-on early clinical development activities for its first-in-human program.

Reporting to the CMO, this senior individual-contributor role owns operational planning, site strategy, and cross-functional execution with CROs and vendors. The leader will manage global study start-up, regulatory coordination, and phase 1 readiness, partnering with internal teams and external partners to move studies forward