Senior Director, Clinical Operations — First-in-Human

flagshippioneeringinc; 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 the hands‑on execution of early clinical development activities for its first‑in‑human program. Reporting to the CMO, this senior individual‑contributor role carries broad ownership and visibility across the organization.

The role requires directing planning, CRO/vendor oversight, and cross‑functional coordination to ensure protocol feasibility, study readiness, and compliant execution across regions.

Qualifications

• Requires leadership of clinical operations in biotech/pharma.
• Experience overseeing early development and first‑in‑human studies.
• Proven ability to manage cross‑functional teams and external partners.

Responsibilities

• Lead clinical operations planning for early development programs and first‑in‑human study readiness.
• Develop integrated study plans, timelines, budgets, and risk mitigation.
• Oversee CRO/vendor selection, negotiations, and performance monitoring.
• Collaborate with Clinical Development and Medical leadership on protocol design and feasibility.
• Represent Clinical Operations on cross‑functional program teams and ensure regulatory alignment.
• Establish site strategy, qualification, activation, and management across regions.

Skills

Project management

Regulatory knowledge

Vendor management

Cross-functional collaboration

Education

BS/MS/PhD in science/healthcare

Job description

Metaphore Biotechnologies, Inc. is seeking a Senior Director of Clinical Operations to lead the hands‑on execution of early clinical development activities for its first‑in‑human program. Reporting to the CMO, this senior individual‑contributor role carries broad ownership and visibility across the organization.

The role requires directing planning, CRO/vendor oversight, and cross‑functional coordination to ensure protocol feasibility, study readiness, and compliant execution across regions.