Sr. Director, Clinical Operations

<p><strong>Company Summary</strong></p> <p>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.</p> <p><strong>Position Summary</strong></p> <p>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.</p> <p>This individual will own clinical operational planning and study execution encompassing CROs and vendor management, site strategy, protocol feasibility, regulatory coordination, and global study start-up, with particular focus on Phase 1 readiness and execution. The successful candidate will be highly operational, able to ramp quickly, and comfortable establishing fit-for-purpose capabilities while working across internal teams, external partners, and consultants to move studies forward with urgency and rigor.</p> <p><strong>Key Responsibilities</strong></p> <ul> <li>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.</li> <li>Develop and maintain integrated study plans, timelines, budgets, forecasts, resource requirements, and risk-mitigation strategies aligned with clinical and corporate objectives.</li> <li>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.</li> <li>Partner with Clinical Development and Medical leadership to evaluate protocols, study designs, operational feasibility, and start-up requirements.</li> <li>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).</li> <li>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.</li> <li>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.</li> <li>Contribute to operational planning for potential studies in China and coordinate with internal and external experts to support regional requirements.</li> <li>Establish an effective operating cadence with CROs, sites, vendors, consultants, and functional partners to track deliverables, timelines, budgets, quality metrics, risks, and escalation paths.</li> <li>Oversee the development and maintenance of study-level operational documentation, including monitoring, communication, enrollment, vendor-oversight, and risk-management plans.</li> <li>Partner with CMC and clinical supply stakeholders to support investigational product packaging, labeling, distribution, accountability, and site readiness.</li> <li>Ensure clinical studies are conducted in accordance with the protocol, ICH-GCP, applicable regulatory requirements, internal procedures, and established quality standards.</li> <li>Maintain inspection-ready clinical trial documentation and oversee the completeness, quality, and timeliness of the Trial Master File.</li> <li>Identify operational risks early and implement mitigation and contingency plans related to timelines, sites, enrollment, vendors, clinical supply, and data delivery.</li> <li>Establish scalable, fit-for-purpose clinical operations processes, systems, SOPs, and governance practices appropriate for a growing biotechnology company.</li> <li>Provide clear and timely updates on study status, timelines, budgets, risks, and mitigation plans to the CMO, clinical leadership, and other key stakeholders.</li> </ul> <p><strong>Required Qualifications</strong></p> <ul> <li>BS/MS/PhD degree in a scientific, healthcare, or related discipline; an advanced degree is preferred.</li> <li>10+ years of progressive clinical operations experience in the biotechnology or pharmaceutical industry.</li> <li>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.</li> <li>Strong working knowledge of CRO and vendor selection and oversight, site strategy, global study start-up, and operational planning.</li> <li>Demonstrated experience managing study budgets, vendor contracts, scopes of work, change orders, timelines, and forecasts.</li> <li>Experience reviewing clinical protocols and translating study designs into execut