Sr. Director, Clinical Operations

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

Company Summary

Metaphore Biotechnologies, Inc. is a privately held biotechnology company building the next generation of biological therapeutics. Inspired by nature, our mission is to transform patient lives by unlocking the power of biological therapeutics with a new proprietary discovery platform. Metaphore's platform brings together live-cell experimentation and AI/ML to understand how biological mechanisms drive functional outcomes in living systems. By capturing these mechanism-function relationships, Metaphore aims to design antibody medicines with intended activity from the start.

Position Summary

Metaphore Biotechnologies is seeking a Senior Director of Clinical Operations to lead the hands-on execution of early clinical development activities for the company's first-in-human program. Reporting to the Chief Medical Officer, this is a senior individual-contributor role with broad ownership and visibility across the organization.

Key Responsibilities

• Lead clinical operations planning and execution for early development programs, with primary accountability for first-in-human study readiness, global start-up, and delivery against key milestones.
• Develop and maintain integrated study plans, timelines, budgets, forecasts, resource requirements, and risk-mitigation strategies aligned with clinical and corporate objectives.
• Lead CRO and vendor selection and oversight, including requests for proposals, bid evaluations, scope-of-work development, budget negotiations, change-order management, performance monitoring, and issue escalation.
• Partner with Clinical Development and Medical leadership to evaluate protocols, study designs, operational feasibility, and start-up requirements.
• Represent Clinical Operations on cross-functional study and program teams, partnering with other relevant functions internally and externally (e.g., Clinical Development, Regulatory, Safety, Clinical Pharmacology, Data Management, Biostatistics, Bioanalytical, CMC, Quality, and clinical supply colleagues).
• Develop and execute the Phase 1 site strategy, including the identification, qualification, activation, and ongoing management of sites with appropriate participant access, clinical pharmacology capabilities, bioanalytical infrastructure, and operational experience.
• Lead global clinical operations activities across the U.S., Europe, Australia, and other ex-U.S. regions, accounting for applicable regulatory, ethics, site, laboratory, vendor, and country-specific start-up requirements.
• Contribute to operational planning for potential studies in China and coordinate with internal and external experts to support regional requirements.
• Establish an effective operating cadence with CROs, sites, vendors, consultants, and functional partners to track deliverables, timelines, budgets, quality metrics, risks, and escalation paths.
• Oversee the development and maintenance of study-level operational documentation, including monitoring, communication, enrollment, vendor-oversight, and risk-management plans.
• Partner with CMC and clinical supply stakeholders to support investigational product packaging, labeling, distribution, accountability, and site readiness.
• Ensure clinical studies are conducted in accordance with the protocol, ICH-GCP, applicable regulatory requirements, internal procedures, and established quality standards.
• Maintain inspection-ready clinical trial documentation and oversee the completeness, quality, and timeliness of the Trial Master File.
• Identify operational risks early and implement mitigation and contingency plans related to timelines, sites, enrollment, vendors, clinical supply, and data delivery.
• Establish scalable, fit-for-purpose clinical operations processes, systems, SOPs, and governance practices appropriate for a growing biotechnology company.
• Provide clear and timely updates on study status, timelines, budgets, risks, and mitigation plans to the CMO, clinical leadership, and other key stakeholders.

Required Qualifications

• BS/MS/PhD degree in a scientific, healthcare, or related discipline; an advanced degree is preferred.
• 10+ years of progressive clinical operations experience in the biotechnology or pharmaceutical industry.
• Direct experience leading first-in-human or Phase 1 studies from operational planning and vendor selection through regulatory and ethics submissions, site activation, first-participant-in, and ongoing execution.