# Sr. Director, Clinical Operations **Company**: Metaphore Biotechnologies, Inc. **Location**: Somerville, MA **Experience**: senior **Job type**: full-time **Salary**: $213,000 - $280,000 **Category**: Healthcare **Industry**: Healthcare **Apply**: https://job-boards.greenhouse.io/flagshippioneeringinc/jobs/8830615002?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_26909f66-57c ## Description 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. 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. 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. - 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. - Strong working knowledge of CRO and vendor selection and oversight, site strategy, global study start-up, and operational planning. - Demonstrated experience managing study budgets, vendor contracts, scopes of work, change orders, timelines, and forecasts. - Experience reviewing clinical protocols and translating study designs into executable operational plans. - Experience supporting clinical pharmacology/DMPK, including dose-escalation, SAD/MAD, biomarker, or other early-phase study designs, as applicable. - Experience conducting studies involving healthy volunteers or specific patient populations. - Broad understanding of FDA, EU, and other ex-U.S. clinical trial requirements. - Strong knowledge of ICH-GCP, sponsor oversight responsibilities, TMF requirements, clinical quality standards, and inspection readiness. - Ability to operate independently and influence without direct authority in a fast-paced environment with limited infrastructure and high levels of ambiguity. - Strong communication and cross-functional collaboration skills, with the ability to manage internal stakeholders, external vendors, and consultants effectively. - Ability and willingness to travel domestically and internationally, as needed. Preferred Qualifications: - Experience in both biotechnology and pharmaceutical company environments, with exposure to the broader clinical development lifecycle. - Direct experience initiating and executing early-phase studies in Australia, including familiarity with local regulatory, ethics, site, and vendor pathways. - Experience with China regulatory and clinical operations pathways. - Experience in antibody therapeutics, biologics, or other advanced therapeutic development programs. - Experience operationalizing biomarker, immunogenicity, pharmacokinetic, pharmacodynamic, or other specialized sample-collection and bioanalytical strategies within early-phase studies. - Experience establishing clinical operations infrastructure, processes, systems, and external partnerships within an organization entering the clinic for the first time. The salary range for this role is $213,000 - $280,000. Metaphore Biotechnologies, Inc. currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. ## Skills ### Required - clinical operations - CRO management - vendor management - study planning - ICH-GCP - regulatory compliance - communication - collaboration ### Nice to have - biotechnology - pharmaceutical industry - antibody therapeutics - biologics - biomarker - immunogenicity - pharmacokinetic - pharmacodynamic --- Source: [Apply at job-boards.greenhouse.io](https://job-boards.greenhouse.io/flagshippioneeringinc/jobs/8830615002?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)