Sr. Director, Clinical Operations

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.